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Distal Femoral Growing Prosthesis: Surgical Protocol

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0% found this document useful (0 votes)
500 views42 pages

Distal Femoral Growing Prosthesis: Surgical Protocol

Uploaded by

Som
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Distal Femoral

Growing
Prosthesis
Surgical Protocol

This document is intended to be used by healthcare professionals only.


Distal Femoral Growing Prosthesis
Surgical Protocol

Table of Contents
Section 1: Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Section 2: Indications and Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Section 3: Stryker Distal Femoral Growing Prosthesis Components
and System Offerings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Distal Femoral Growing Prosthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Stem Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Extension Pieces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Total Femur. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Tibial Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Instrumentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Section 4: Primary Surgical Technique. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Pre-Operative Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Exposure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Planning the Resection Length. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Rotational Alignment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Femoral Osteotomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Femoral Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Proximal Tibial Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Tibial Resection Level. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Proximal Tibial Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Tibial Preparation for the Pediatric All Poly Tibial Component. . . . . . . . . . . . . 20
Trial Reduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Assembly of the Femoral Prosthesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Implantation and Orientation of the Femoral and Tibial Components. . . . . . . 27
Appendix I: Expansion of the Stryker Distal Femoral Growing Prosthesis. . . . . . . 30
Incision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Unlock Prosthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Expansion of the Prosthesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Re-lock the Prosthesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Appendix II: Taper Disassembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Appendix III: Growing Prosthesis Sterilization Instructions . . . . . . . . . . . . . . . . . . 33
Catalog. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Distal Femoral Growing Prosthesis
Surgical Protocol

Section 1: Introduction
The Stryker Distal Femoral Growing Prosthesis provides a means to reconstruct
large bone defects resulting from bone resection in skeletally immature patients.
The device can be expanded as a patient grows so that leg-length equality can
be achieved. The device utilizes a rotating hinge design. The expansion process
is mechanical and is conducted with subsequent minimally invasive procedures
following the initial implantation surgery.

The system consists of distal femoral components, extension pieces, and stems.
It also includes a complete set of trial components and instrumentation.

The modular implants are assembled by impacting a male/female taper design,


securely locking them together.

Section 2: Indications and Contraindications


The Stryker Distal Femoral Growing Prosthesis is indicated for pediatric patients
who have not achieved full skeletal maturity (open epiphysis), where radical
resection and replacement of the distal femur and/or proximal tibia is required with
the following conditions:
• Oncology indications
• Severe trauma
• Noninflammatory degenerative joint disease including osteoarthritis
• Correction of functional deformity
• Rheumatoid arthritis
• Revision procedures where other treatments or devices have failed

The devices are single use implants intended only for implantation with bone
cement.

The contraindications for use of the Stryker Distal Femoral Growing Prosthesis
include:

1. As related to Bone Tumors


Not all bone tumors may be treated successfully by segmental resection. Any
condition that may have already resulted in either local or distant spread of the
tumor may be a contraindication. Examples of such conditions include:
• Pathological fracture;
• Overt infection;
• Inopportune placement of biopsy incision; and,
• Rapid disease progression beyond a respectable margin.

2. Adult or skeletally mature patients (at time of surgery)


3. Skeletally immature patients who have insufficient soft tissue for closure.
4. Any active or suspected latent infection in or about the operative joint.
5. Any mental or neuromuscular disorder which would create an unacceptable
risk of prosthesis instability, prosthesis fixation failure, or complications in
postoperative care.
6. Bone stock compromised by disease, infection or prior implantation which
cannot provide adequate support and/or fixation to the prosthesis.
7. Any patellar deficiency that would require use of a patellar component.

SEE PACKAGE INSERT FOR WARNINGS, PRECAUTIONS, ADVERSE


EFFECTS AND OTHER ESSENTIAL PRODUCT INFORMATION.
2
Section 3: Stryker Distal Femoral Growing
Prosthesis Components and System Offerings

Distal Femoral Growing


Prosthesis

Polyethylene
Bearing

Axis

Circlip

Tibial Bearing
Component Wedge

Distal Femoral Growing Prosthesis

The Distal Femoral Growing Prosthesis is available in left and right configurations,
and replacement lengths from 150mm to 200mm in 10mm increments. The Distal
Femoral Growing Prosthesis measures 43.5mm in the A/P and 45mm in the M/L.

Caution:

Not all sizes are readily available. Please contact your Stryker sales representative
regarding availability at the beginning of the treatment cycle to ensure device
availability.

The Distal Femoral Growing Prosthesis, after initial implantation, may be


expanded utilizing two hex screwdrivers. A 2mm Hex Screwdriver is utilized to
lock/un-lock the prosthesis, and a 3.5mm Hex Screwdriver is utilized to
expand/retract the prosthesis.

3
Distal Femoral Growing Prosthesis
Surgical Protocol

Stem Components
The GMRS cemented stems are available in six styles: straight, curved and long
curved; each style with or without extra-cortical porous-coated body sections.
The extra-cortical porous-coated body section has a 40mm replacement length.
The stems are also available without the extra-cortical porous-coated body section,
with an 11mm replacement length.

All stems are available in 8, 9 , 10, 11, 13, 15 and 17mm diameters. Their respective
seat diameters at the resection level are as follows:

GMRS Cemented Stem Options Available for the Growing Distal Femur
Stem Diameter Seat Diameter Straight Stem Length Bowed Stem Length

8mm 22mm 102mm 102mm


9mm 22mm 102mm 102mm
10mm 24mm 102mm 102mm
11mm 24mm 127mm 127mm, 203mm
13mm 28mm 127mm 127mm, 203mm
15mm 32mm 127mm 127mm, 203mm
17mm 36mm 127mm 127mm, 203mm

The stems are designed to be cemented into the medullary canal. Optional stem
centralizers are available for the 10-17mm diameter (for the straight and
short-curved stems only).

Extension Pieces
The extension pieces are used to customize the replacement length and are
available in 30, 40, 50, 60, 70, 80, 100, 120, 140, 160, 180, 200, and 220mm lengths.
This component features a male and female taper, which attaches a stem to a
distal femoral component.

4
Total Femur

The Growing Prosthesis can also be assembled to a connection piece and proximal
femoral component to reconstruct the entire femur.

The proximal femoral components are available in two styles, standard and
trochanteric. The components are available in three different configurations but
only the neutral configuration should be used for total femoral replacement. All
components have a replacement length of 70mm, which is measured to the center
of the standard length (zero offset) femoral head. The components accept Stryker
femoral head implants with the 5°40’ taper (V40 femoral heads). The proximal
femoral components have a 135° neck angle and fixation holes to re-attach the
abductor mechanism.

The connection pieces are available in 80 or 90mm replacement lengths and left
and right configurations. This component features a double male taper design
to connect the Distal Femoral Growing Prosthesis to either a proximal femoral
component or an extension piece if additional replacement length is required.

Tibial Components

There are three tibial component options for use with the Distal Femoral Growing
Prosthesis: the Pediatric All-Polyethylene Tibial Component, the Modular Rotating
Hinge Tibial Baseplate, and the GMRS Small Proximal Tibia. Each tibial component
option requires a different Tibial Bearing Component:

Tibial Component Options and Associated Tibial Bearing Components

Tibial Component Tibial Bearing Component

Pediatric All Poly Tibia 6497-2-301


MRH Tibial Baseplate 6497-2-302
GMRS Proximal Tibia
GMRS Small Proximal Tibia 6497-2-303

5
Distal Femoral Growing Prosthesis
Surgical Protocol

Pediatric All-Polyethylene Tibial Component

The Pediatric All-Polyethylene Tibial Component is available in two sizes (PT1


and PT2), each in 2 thicknesses (8 and 11mm) and are made from DURATION
Stabilized Ultra High Molecular Weight Polyethylene (UHMWPE).

Modular Rotating Hinge Tibial Baseplate

If the bone quality is suspect or the component cannot be properly supported, the
Modular Rotating Hinge (MRH) tibial baseplate is recommended.

The MRH Tibial Baseplate is available in four sizes (Small 1, Small 2, Medium 2
and Large 2), with modular stem options (80 and 155mm lengths, 10-23mm
diameter). The tibial inserts are available in two sizes (Small 1 / Small 2 and Medium
2 / Large 2), each in 5 thicknesses (10, 13, 16, 20, and 24mm) and are made from
DURATION Stabilized Ultra High Molecular Weight Polyethylene (UHMWPE).
A comprehensive range of modular stem extensions are available to be assembled
with these Tibial Baseplates.

GMRS Proximal Tibial Component

The GMRS Proximal Tibial Component is available in two sizes (Small and
Standard) and has a replacement length of 80mm, measured to the sulcus of the
thinnest, 10mm, tibial insert. The Proximal Tibial Component has fixation holes
in the Anterior-Posterior (A/P) and Medial-Lateral (M/L) direction to re-attach
soft tissues. The Proximal Tibial Component accepts the small GMRS Tibial Inserts
(6495-3-0XX). The tibial inserts are available in five thicknesses (10, 13, 16, 20, and
24mm) and are made from DURATION Stabilized Ultra High Molecular Weight
Polyethylene (UHMWPE). The GMRS Small Proximal Tibial Component accepts
the GMRS cemented stems.

Instrumentation

The Distal Femoral Growing Prosthesis utilizes a combination of selected


instrumentation from the GMRS Instrument Set and selected other instruments.
Please refer to the instrument bars throughout the technique and the instrument
listing on page 34 through 35.

6
Section 4: Primary Surgical Technique
Pre-Operative Plan

• The primary goal is wide resection of the lesion or affected area.


• The extent of the tumor and/or the amount of resection required should be
determined during pre-operative planning.
• Depending on the patient’s expected remaining growth, the surgeon can
determine if an expandable prosthesis is the appropriate treatment. If this is the
case, the patient’s expected remaining growth should be used to appropriately
plan for future expansions of the device.

Distal Femur Resection Lengths and Maximum Expansion


Distal Femur Replacement Lengths*

Stem without Body = 11mm


Stem with Body = 40mm
Total Replacement Length (L) Maximum
Stem without Body Stem with body Expansion

150mm 179mm 35mm


160mm 189mm 45mm
170mm 199mm 55mm
180mm 209mm 65mm
190mm 219mm 75mm
200mm 229mm 85mm

Caution:

Not all sizes are readily available. Please contact your Stryker sales representative
regarding availability at the beginning of the treatment cycle to ensure device
availability.

Exposure

> Tumor exposure is gained through an extensile approach as dictated by the


tumor or necessary resection.

> An applicable approach is an anterior approach with a medial parapatellar


arthrotomy. However a lateral approach will allow for future expansions of the
device through the same incision.

> Biopsy tracts are incorporated into the incision and elipsed out.

> Tumor and any soft tissue extension is exposed through careful dissection.

> Collateral and cruciate ligaments are dissected from the tibia.

> Bone segment is measured and resected en bloc based on pre-operative plan.

> Tumor margins are confirmed.

> Femoral osteotomy is planned.

7
Distal Femoral Growing Prosthesis
Surgical Protocol

Planning the Resection Length

> The resection length of the Stryker Distal Femoral


Growing Prosthesis is both marked on the device and
included on the label of the device. The Distal Femoral
Template from the GMRS Instrument Set can be used
to select resection level that can be reproduced by
the available implants. The Distal Femoral Template
is placed on the bone so that the silhouette of the
template coincides with the distal condyles of the femur
(Figure 1). The Distal Femoral Template is read at the
appropriate marking depending on whether the
stem being used is with or without extra-cortical
porous-coated body section.

With regards to the resection length the following must be


Figure 1: Distal Femoral Template taken into account when planning for the tibial cut:
> If the surgeon intends to use the Modular Rotating
Hinge (MRH) baseplate with the Stryker Distal Femoral
Growing Prosthesis, an 18 mm resection is usually
required for the MRH baseplate. Typically, 10-12mm of
bone from the medial tibial sulcus is removed from the
proximal tibia and the femoral resection is therefore,
6-8mm longer than the prosthesis. However if the tibial
growth plate is still open, a 2mm resection from the
medial tibial sulcus of the proximal tibia preserves the
growth plate, allows for continued tibial growth and
requires less expansion of the prosthesis. The joint line
corrects over time as prosthesis expansion exceeds
tibial growth.

> Alternatively, the MRH/All-Poly Tibial Template can


be attached to the Distal Femoral Template. The slots
in the Tibial Template coincide with the level of the
proximal tibial resection for the different All-Poly Tibial
components or the MRH Tibial Insert thickness options
(Figure 2). This is a provisional marking only; no bone
resection is performed at this time. The resection is
made at a later point in the procedure utilizing EM
alignment instrumentation.

> If the surgeon intends to use the Proximal Tibia, please
refer to the GMRS Proximal Tibial Surgical Protocol
(LSPK39) for instructions on planning the tibial
resection.
Figure 2: MRH/All-Poly Tibial Template
8
Instrument Bar

6496-9-069
Distal Femoral Template

The anterior
cortex of the
femur is marked
with a Bovie or 6496-9-071
similar device MRH/All Poly Tibial Template
to indicate the
resection level.

Measurement

Figure 3: Total Resection Measurement

Please refer to the table below to equate the Distal Femoral


Template to equivalent lengths of Growing Prosthesis construct:

Note:

It is important to ensure proper patellar tracking by means


of proper placement of the device. The length of the femoral
resection and prosthetic replacement must be considered
with the tibial resection to recreate leg length and establish
proper patellar tracking. Preservation of the tibial growth
plate, patellar tracking, tibial resection, and leg length
must be taken into consideration when making the femoral
resection.

Tech Tip:

As an aid to restoring leg length, a reference measurement


can be established across the joint. A mark is made on the
femur, proximal to the femoral resection, along with a
mark on the tibia, distal to the tibial resection. (Figure 3)
The distance between these marks can be measured before
the resection is made, and checked again, with the trials or
implants in place, after the resection is made.
9
Distal Femoral Growing Prosthesis
Surgical Protocol

GMRS Distal Resection Template


Measurement Femoral Component
Without Body With Body Length (L)

+70 +40 150mm


+80 +50 160mm
+60 170mm
+100 +70 180mm
+80 190mm
+120 200mm
+100 150mm + 60mm Body
Segment
+140 150mm + 70mm Body
Segment
+120 150mm + 80mm Body
Segment

L +140 150mm + 100mm Body


Segment

Caution:

Not all sizes are readily available. Please contact


your Stryker sales representative regarding availability
Figure 3A: Replacement Length Measurement at the beginning of the treatment cycle to ensure
device availability.

Rotational Alignment

> Using a straight edge, the anterior cortex of the distal


femur is marked above the resection level in line with
the trochlear groove of the distal femur (Figure 4).

> The line should be directly anterior to the linea


aspera. This reference mark will be used later to aid in
rotational orientation of the prosthetic components.
Rotational alignment can also be determined or verified
during trial evaluation.

> The Stem Implants and Trials are marked in line


with the trochlear groove of the Distal Femoral
Component. As a guide to rotational orientation, the
alignment marking on the implant stem can be oriented
to the mark made on the anterior cortex above the
resection level.
Figure 4:
Marking for Rotational Alignment

10
Instrument Bar

6496-9-069
Distal Femoral Template

6496-9-071
MRH/All Poly Tibial Template

Figure 5: Osteotomy

Femoral Osteotomy

Tech Tip:

It is preferable to resect the femur a millimeter or two distal


to the marked resection level. This will allow the Facing
Reamer to plane accurately up to the mark at a 90° angle.

Note:

It is extremely important not to distract the extremity


following the resection. The end of the femoral osteotomy
should be kept well padded to protect the femoral vessels.
The length of the resected specimen should be checked and
measured again following resection.

11
Distal Femoral Growing Prosthesis
Surgical Protocol

Femoral Preparation

> Flexible or rigid reamers can be utilized to prepare


the femoral canal (Figure 6). If flexible reamers are
utilized, a flexible guide wire is inserted into the
Figure 6: femoral canal. Reamers are utilized to progressively
Preparation of the ream the canal to the appropriate diameter. To allow for
femoral canal an adequate cement mantle, the canal should be reamed
to 2mm larger than the selected stem of the prosthesis.

Note:

The seven stem diameters are 8mm, 9mm, 10mm, 11mm,


13mm, 15mm and 17mm.

> The appropriate Facing Reamer is used to plane the


Stem Suggested Flexible Seat
Diameter Reamer Diameter Diameter
osteotomy site so as to ensure direct contact and
accurate seating of the prosthesis upon the cortices.
8mm 10mm 22mm
> The chosen Trial Stem is inserted to evaluate ease of
9mm 11mm 22mm insertion and an appropriate cement mantle. The trial
cemented stems are exactly size for size as compared to
10mm 12mm 24mm
the implant and do not account for the cement mantle.
11mm 13mm 24mm

13mm 15mm 28mm


> If there is any difficulty inserting the trial stem, continue
progressively reaming until the Trial Stem fits freely into
15mm 17mm 32mm the canal, or re-assess the Trial Stem size. It is extremely
17mm 19mm 36mm important to verify the close apposition of the seat of the
Trial Stem to the cortex.

PMMA
Flexible Reamer Distal Centralizer > Optional stem centralizers are available for the
10-17mm diameter stems (for the 102 and 127mm
length stems only). The last size reamer used
corresponds to the diameter of the distal centralizer
necessary for correct positioning of the stem tip.

15mm 15mm

Figure 7
12
Instrument Bar

Proximal Tibial Resection 6496-9-2XX


Facing Reamer
> This technique illustrates the preparation for the
Pediatric All-Poly Tibial Component which articulates
with the Distal Femoral Growing Prosthesis.

• The technique for the Modular Rotating Hinge See Catalog


Tibial Baseplate which also articulates with the Cemented Stem Trial
Distal Femoral Growing Prosthesis, is illustrated
in the GMRS Distal Femoral Surgical Protocol
(LSPK38).

• The technique for the GMRS Proximal Tibia


which also articulates with the Distal Femoral
Growing Prosthesis, is illustrated in the GMRS
Proximal Tibial Surgical Protocol (LSPK39).

> The required proximal tibial cut is neutral to the tibial


axis in all planes, i.e. cut in classic alignment with no
posterior slope. The amount of tibial bone removed in
addition to the planned femoral resection will need to
be replaced in order to reconstruct pre-operative leg
length.

> The instrumentation provides four options for


determining the resection level of the proximal
tibia. This technique illustrates the method for
establishing the depth of the tibial cut referenced from
extramedullary referencing.

• The other three options can be reviewed in


the GMRS Distal Femoral Surgical Protocol
(LSPK38).

13
Distal Femoral Growing Prosthesis
Surgical Protocol

Fixation Pins > With the knee flexed, place the EM Tibial Alignment
Guide on the tibial shaft. Place the Ankle Clamp
EM Tibial around the distal tibia just above the malleoli.
Alignment Guide
> Place the Fixation Pins of the instrument over the
tibial eminence. There should be a finger’s breadth
clearance between the proximal shaft of the Alignment
Guide and the anterior cortex when the Fixation Pins
are positioned properly. Center the Proximal Fixation
Pins over the tibial eminence and tap in the most
posterior pin first to fix the anterior/posterior location
of the head. Rotation is now adjusted and then set by
Proximal anchoring the second pin. Tighten the vertical screw to
Shaft secure the proximal shaft of the guide.

Figure 9
Vertical
Screw

Medial/Lateral
Adjustment Screw

Ankle
Figure 8 Clamp

Anterior/Posterior
Adjustment Screw

14
Instrument Bar

8000-1040
EM Tibial Ankle Clamp

8000-1056
EM Tibial Spiked Proximal Rod
Alignment Guide

Figure 10

> Axial alignment is achieved when the vertical shaft of


the instrument parallels the long axis of the tibia in
both the anterior/posterior and medial/lateral planes
(Figures 9 and 10).

15
Distal Femoral Growing Prosthesis
Surgical Protocol

> Landmarks used to obtain correct axial alignment and


rotation are:

Second Metatarsal – The second metatarsal generally


is in line with the center of the ankle (Figure 11).

> Once axial alignment is established, tighten the


Figure 11 anterior/posterior and medial/lateral adjustment
thumbscrews (Figure 12).

Anterior/
Posterior
Adjustment Tibial Resection Level
Screw
> If templates were used to plan the tibial resection level
earlier in the procedure, this marking can be used as
Medial/ a guide.
Lateral > Alternatively, a tibial stylus can be utilized to set the
Adjustment tibial resection level. Assemble the Tibial Stylus to the
Screw Tibial Resection Guide by depressing the locking button
on the top of the Tibial Stylus, inserting the stylus into
either the medial or lateral holes on the top of the Tibial
Figure 12 Resection Guide and releasing the button to lock the
Stylus into place (Figure 13).

> The Stylus has two depth setting options for the Tibial
Resection Guide (12 or 18mm), depending on which
Locking Button end of the stylus is used. An 18mm resection from the
medial tibial sulcus is required from the tibia if the
distal most aspect of the femoral replacement is placed
at the same level of the original anatomy. Typically, a
12mm resection from the medial tibial sulcus would
Tibial Stylus be preferred, which requires resecting an additional
Tibial
Resection Guide 6mm from the femur. However if the tibial growth plate
is still open, a 2mm resection from the medial tibial
sulcus of the proximal tibia preserves the growth plate,
allows for continued tibial growth and requires less
expansion of the prosthesis. The joint line corrects over
time as prosthesis expansion exceeds tibial growth.

> The level of the patella should be checked to optimize


proper patellar position.
Figure 13
16
Instrument Bar

8000-1040
EM Tibial Ankle Clamp

8000-1056
Spiked Proximal Rod

Proximal
Shaft
7650-1072
Tibial Stylus

6496-9-051/052
Tibial Cutting Block

Figure 14

> Attach the Tibial Resection Guide/Tibial Stylus


assembly to the External Tibial Alignment Guide by
sliding it over the top of the proximal shaft, adjusting
the stylus to reference the desired point on the tibial
plateau (Figure 14).

17
Distal Femoral Growing Prosthesis
Surgical Protocol

Proximal Tibial Resection

> Secure the Tibial Resection Guide to the proximal tibia


using two 1/8” Drill Pins, drilling through the “N”
holes. Loosen the thumbscrew that holds the Tibial
Proximal Resection Guide to the External Tibial Alignment
Shaft Guide. Loosen the vertical adjustment thumbscrew on
the shaft of the Alignment Guide.

> Extract the two headed Fixation Pins on the top of the
Alignment Guide from the proximal tibia. Remove the
proximal shaft of the Alignment Guide by sliding it up
through the top of the Resection Guide (Figure 15).
Tibial > Slide the Tibial Resection Guide posteriorly until it
Resection comes in contact with the anterior tibia. Placing a 1/8”
Guide Drill Pin through the “X” pin hole will further secure
the Resection Guide to the tibia.

> The Alignment Handle may be used with an Alignment


Pin, referencing the same landmarks as outlined
previously to verify proper alignment.

Vertical
Thumb
Screw

Figure 15

> Resect the plateau using a .050” (1.27mm) Saw Blade


(Figure 16).

Figure 16
18
Instrument Bar

8000-1040
EM Tibial Ankle Clamp

8000-1056
Spiked Proximal Rod
Tibial
Resection
Guide
6496-9-051/052
Tibial Cutting Block

Figure 17
7650-1035
> If desired, 2mm or 4mm of additional bone may be Headless Pin Driver
resected by repositioning the guide over the pins
through the -2 or -4 holes respectively

7650-1038
Note: Headless Pins

If the “X” Pin hole is used, this pin must be removed prior to
repositioning the Tibial Resection Guide.
6633-7-250
> The Tibial Resection Guide is removed by first Alignment Handle
removing the “X” pin, then sliding the guide off over
the two 1/8” drill pins.

6838-7-220/230
Alignment Pin

6633-7-605
Pin Puller

19
Distal Femoral Growing Prosthesis
Surgical Protocol

Tibial Preparation for the Pediatric


All Poly Tibial Component

> Select the appropriate Pediatric Tibial Template


and lock it onto the Tibial Alignment Handle. The
appropriate size Template will achieve cortical support
around the periphery of the template.

> The long Alignment Pin assembled with the Alignment


Handle verifies rotational, Varus/Valgus, and flexion/
extension alignment (Figure 18).

Figure 18

> Rotational alignment is correct when the drill bit placed


in a hole from the tibial resection step is parallel to the
handle (Figure 19). Varus/Valgus and flexion/extension
is verified with a Long Alignment Pin.

> Holes are located on the anterior face and posterior


surface of the Template. Headed Nails or drills through
these holes may be used to temporarily fix the Template.

Note:

It is important that the correct size be selected to fully


support the All-Poly Tibial Component around the
periphery with cortical bone.

Figure 19

> Using the Pediatric Stem Drill, prepare for the central
tibial stem by drilling through the raised central hole in
the Pediatric Tibial Template (Figure 20).

> The Pediatric Stem Drill has a stop and will bottom out
on the Pediatric Tibial Template.

Figure 20
20
Instrument Bar

6737-8-500/505
Pediatric Tibial Template

6633-7-250
Alignment Handle

6838-7-220/230
Alignment Pin

7650-1038
Headless Pins

6737-8-510
Pediatric Stem Drill

Figure 21
8000-7845
Counter Sink Drill
> Then complete the tibial preparation by using the
Counter Sink Drill to prepare for the tibial pegs
through the two posterior raised holes in the Pediatric
Tibial Template (Figure 21). 7650-1035
Headless Pin Driver
> Both drills have a stop and each drill should bottom out
on the Pediatric Tibial Template.

> Remove the headed nails with the Headed Nail


Impactor/Extractor and remove the Pediatric Tibial
6633-7-605
Template.
Pin Puller

6633-7-610
Headed Nail Impactor Extractor

6633-7-600/615
Headed Nails

21
Distal Femoral Growing Prosthesis
Surgical Protocol

Trial Reduction

> The purpose of the trial reduction is to determine the


ease of insertion of the femoral and tibial components
prior to cementation, and to determine whether the
length of the prosthesis is appropriate. If the prosthesis
is too long, too much tension will be placed upon the
neurovascular structures when the knee is extended. In
addition, the extensor mechanism will be tight, causing
loss of flexion and difficulty in closing the soft tissues.

> The two most important factors in accepting final


length are:

1. Proper patellar tracking

2. Distal pulses

> To determine the appropriate length, one must extend


the knee and monitor the distal pulse with the trial
prosthesis in place. Based on tibial component selection,
insert the appropriate tibial trial into the tibia, and
impact it until it is flush with the tibial osteotomy.
The GMRS Small Distal Femoral trials are used in
conjunction with extension piece trials to recreate the
length of the Distal Femoral Growing Prosthesis for
purposes of trial reduction:

Femoral
Component Equivalent GMRS Trial Construct
Length

150mm 70mm Extension Piece


Trial

160mm 80mm Extension Piece


Trial

170mm GMRS 60mm + 30mm Extension


Small Distal + Piece Trials
Femoral Trial
180mm 100mm Extension Piece
Trial

190mm 80mm + 30mm Extension


Piece Trials

200mm 120mm Extension Piece


Trial

Caution:

Not all sizes are readily available. Please contact


your Stryker sales representative regarding availability
at the beginning of the treatment cycle to ensure
device availability.

Figure 22
22
Instrument Bar

6496-2-010/020
Distal Femoral Trial - Small

6496-6-0X0
Trial Extension Piece

See Catalog
Cemented Stem Trial

Figure 23

> Construct the Trial Femoral Prosthesis by joining the


Trial Cemented Stem with the Trial Extension Piece
and with the Trial Distal Femoral Component. Insert
the stem of the trial femoral assembly into the femur.
As a guide to rotational orientation, align the rotational
alignment mark on the femoral stem segment with
the rotational reference mark previously made on the
anterior cortex of the femur (Figure 23).

23
Distal Femoral Growing Prosthesis
Surgical Protocol

> Insert the Trial Tibial Bearing Component into the tibial trial. Bring the
Trial Tibial Bearing Component up between the femoral condyles and
insert the Trial Axle. Then insert the Trial Bumper through the anterior
hole of the Trial Tibial Bearing Component (Figure 24). Hold the trial
Trial Cemented
femoral assembly in one hand to prevent rotation and fully extend the
Stem
leg. Palpate the femoral vessels to determine the status of the pulse. If
the pulse is diminished, flex the knee to determine if it increases. This
will indicate the need for either modifying the length of the prosthesis
or for removing additional bone from the distal femur or proximal tibia.

Tech Tip:

As an aid in checking leg length, the distance between the leg-length


Trial Extra-
Cortical Body reference marks on the tibia and femur can now be rechecked.
(30mm Trial
Extension Piece)
> In order to determine if proper patellar tracking has been achieved,
the final femoral implant construct must be assembled (See Assembly
of the Femoral Prosthesis on pages 25 and 26). Insert the femoral
implant construct into the femoral canal without cement. Manipulating
the knee through its range of motion may be used to determine the
appropriate rotation of the femoral component. If the evaluation
identifies a rotation different than that already marked, an additional
mark should be made or the rotation should be noted relative to the
existing mark. Slight external rotation may aid in patellar tracking.

Trial Extension > A final test of the range of motion of the knee with the patella tracking
Piece in place is then performed. A full range of motion should be obtained.
Note whether the capsular mechanism can be closed. These factors,
taken together, will determine the adequacy of the length of the
Trial Distal resection.
Femoral
Component > If it is determined that the prosthetic construct is too long, the length
of the distal femoral bone resected should be rechecked against the
length of the assembled prosthesis. The primary means to address a
construct that is too long should be to remove additional bone from the
femur. Other alternatives include shortening the prosthesis (if it has
been expanded), selecting a shorter extension piece (if applicable), or
evaluation of a thinner tibial construct if possible.
Trial Axle
> If it is determined that the prosthetic construct is too short, expand the
prosthesis to the appropriate length (See Expansion of the Stryker Distal
Femoral Growing Prosthesis on pages 30 through 32).

Trial Bumper Tech Tip:

The replacement length should err on the side of being too short rather
Trial Tibial than too long. A reconstruction that is too long can lead to challenges
Bearing with wound closure. Additionally, with children maintaining motion is
Component critical. Children have the potential to lose motion over time as they are
not as disciplined as adults in following their physical therapy regimen.

> The decision can now be made if a gastrocnemius flap or muscle transfer
Pediatric All Poly will be required, dependent upon the presence or absence of the capsule
Tibial Trial Figure 24 or portions of the quadriceps.

24
Instrument Bar

See Catalog
Cemented Stem Trial

6496-6-0X0
Trial Extension Piece

6496-2-010/020
Distal Femoral Trial - Small

6496-2-115
Figure 25
Trial Axle

Assembly of the Femoral Prosthesis

> The femoral prosthesis consists of the Stem, Extension 6481-4-107


Piece (when needed based on the length of the Trial Tibial Bearing Comonent - Pediatric
reconstruction), and the Distal Femoral Component.
Check that the correct side (left or right) and
replacement length for the Distal Femoral Growing
Prosthesis, and that the correct sizes of all other 6496-2-130/133
components have been chosen before assembly. If Trial Bumper
necessary, it is acceptable to stack two Extension Pieces
to construct the necessary length. The instruments used
for the assembly of the prosthesis are the Impaction
Tube, the appropriate Impaction Tube Insert, the 5-in-1
6496-9-053
Impactor and the Impaction Block, if necessary, along
Impaction Tube
with a Mallet.

> The Impaction Tube Insert corresponding to the


stem diameter is assembled to the Impaction Tube
(Figure 25). 6496-9-065/066
Impaction Insert

6486-8-0XX
Trial Pediatric All Poly Tibia

25
Distal Femoral Growing Prosthesis
Surgical Protocol

> The Extension Piece (if required) and the cemented


Stem are assembled first. The cemented Stem is placed
into the Impaction Tube and the Extension Piece is
mated with it. The 5-in-1 Impactor is placed over the
taper of the Extension Piece and impacted with a heavy
Mallet to lock the tapers (Figure 26).

Figure 26

> Next, the Stem/Extension piece construct is assembled


to the Distal Femoral Component. Place the Distal
Femoral Component onto the Extension Piece or Stem.
The 5-in-1 Impactor is inserted between the condyles
of the Distal Femoral Component so that its handle is
parallel to the axis of the bushing holes and impacted
with a Mallet (Figure 27).

Figure 27

> If a 203mm long curved cemented Stem is to be


implanted, the Distal Femoral Component is inserted
into the Impaction Support Block. An Extension
Piece, if required, is inserted into the Distal Femoral
Component and then the appropriate diameter
cemented Stem is inserted into the Extension Piece or
Distal Femoral Component (Figure 28).

> Verify that the bow of the cemented stem curves


towards the posterior of the Distal Femoral
Component. The Impaction Tube is inverted and placed
over the cemented Stem and impacted with a heavy
mallet, or by sliding the Impaction Tube over the stem
like a Slap Hammer.

Figure 28
26
Instrument Bar

Implantation and Orientation of the Femoral


and Tibial Components
6496-9-053
> Please reference the following surgical technique for Impaction Tube
assembly and implantation of each tibial option for use
with the Stryker Distal Femoral Growing Prosthesis:
6496-9-063
• All-Polyethylene Tibia: LSPK38 (Appendix II) 5-In-1 Impactor/Wrench
• MRH Baseplate: LSPK38
• GMRS Proximal Tibia: LSPK39

Tech Tip:
6496-9-064
If a stem centralizer is not being used, plug the hole in Impaction Support Block
the stem with bone cement.

> The prosthesis is then inserted into the femoral canal


until the stem seat is flush with the host bone at the
6496-9-065/066
osteotomy site. Excess cement is removed from around
Impaction Insert
the prosthesis. Care is taken to prevent cement from
getting into the Extra-Medullary porous-coated section.
It is firmly held in place at the rotational orientation
determined by the trial reduction while the cement cures.

Tech Tip:

When cementing the tibial component, it is best to not


cement through the tibial growth plate, and to select a stem
that will engage the diaphyseal tibial cortex to facilitate
continued healthy tibial growth.

27
Distal Femoral Growing Prosthesis
Surgical Protocol

> Place the polyethylene bearing through the proximal


hole of the Tibial Bearing Component. Then, insert the
bearing in between the condyles of the housing of the
Distal Femoral Growing Prosthesis, and then insert the
metal Axis through the construct (Figure 29).

Note:

Check the rotational alignment of the prosthesis again


and if it is adequate, the Axis of the prosthesis should be
inserted from the side of the skin incision by hand.

If the GMRS Proximal Tibia or MRH Tibial


component has been selected:
> With the Femoral Prosthesis and Tibial Baseplate
Figure 29 implanted, prior to selection of the final tibial insert
thickness, it is possible to use the Distal Femoral
Growing Prosthesis assembled with Axis, Tibial
Bearing Component and Trial Tibial Insert to verify
that the appropriate motion, stability and patellar
tracking have been achieved. It is recommended not to
assemble the wedge or circlip until the final tibial insert
has been assembled to the baseplate. With the knee in
full extension this also assists in loading the femoral
and tibial baseplate components while the cement is
curing to provide an optimal bond between implant
and bone.

> Once the tibial insert thickness has been determined,


deconstruct the Axis and Tibial Bearing Component
and remove the Trial Tibial Insert. Snap-in the
appropriate thickness Tibial Insert corresponding
to the tibial component, drop in the Tibial Bearing
Component, and reinsert the Axis (Figure 30).
Figure 30

> A hemostat should be utilized to assemble the circlip


to the prosthesis. Insert the each tip of the forceps into
one of the loops of the circlip. Reduce the diameter of
the circlip by squeezing it, and place the circlip in the
groove on the inside of the Axis counterbore. Release
the circlip once it is fully engaged within the channel
(Figure 31). The clip can be placed on either the medial
or lateral side of the implant based upon intraoperative
ease of exposure.

Tech Tip:

A right angle hemostat may provide more control in


inserting the circlip. Serrated teeth will aid in retention
of the circlip in the hemostat prior to insertion. By
assembling the circlip on the lateral side, it can be
Figure 31 accessed through the same incision as the expansion
mechanism.
28
Instrument Bar

6497-2-300
2mm Hex Screwdriver for Distal Femoral
Growing Prosthesis

Figure 32

> The wedge is then inserted by hand (pressed in) into


the bore on the bearing component (Figure 32). If the
wedge sits too proud, soft impaction with a mallet may
be conducted.

Clockwise

Figure 33

> Ensure that the device is locked prior to closure. Insert


the smaller hex screwdriver into the locking hole and
turn clock-wise (Figure 33). An audible click from the
locking screwdriver handle will indicate that the device
is locked.

29
Distal Femoral Growing Prosthesis
Surgical Protocol

Appendix I: Expansion of the


Stryker Distal Femoral Growing
Prosthesis
Expansion
Screw > The Distal Femoral Growing Prosthesis can be
expanded using a minimally invasive procedure
Locking
following the initial implantation surgery as
Screw
determined by the patient’s growth.

Figure 34

Incision
> A lateral approach is utilized. For the initial
expansion, a 1-2cm incision is made as close to the
locking and expansion screws as possible
(Figure 35). For subsequent expansions, the incision
should be made along the original incision site.
The locking and expansion screws can be located
by palpation or fluoroscopic imaging.

Note:

If utilizing the identical incision site for subsequent


lengthening procedures, the locking and expansions
screws will progressively move distally relative to the
Figure 35 incision.

Unlock Prosthesis
> Once exposure to the device has been gained on the
Counter-Clockwise lateral side, to unlock the expandable prosthesis, insert
the smaller hex screwdriver into the hole indicated and
turn counter-clockwise (Figure 36). Do not bend the
screwdriver. Ensure that the smaller hex screwdriver is
fully seated in the hole prior to unlocking the device.

Caution:

Unlocking the prosthesis requires loosening of the


locking screw only. Do not continue to turn the locking
screw counter-clockwise after loosening it. The smaller
Figure 36 hex screwdriver is only torque limiting in the locking
30 direction.
Instrument Bar

6497-2-300
2mm Hex Screwdriver for Distal Femoral
Growing Prosthesis
Counter-Clockwise

702429
Teardrop Handle Large w/AO Quick Fitting

1806-0292
Screwdriver Shaft, 3.5 x 85mm

Figure 37

Expansion of the Prosthesis

> After unlocking the prosthesis, insert the larger hex


screwdriver into the device in the hole indicated
(Figure 37). Turn counter-clockwise as required
to expand the prosthesis. One complete turn of the
screwdriver is equivalent to approximately 1mm
of expansion.

Tech Tip:

It is recommended to expand at intervals where at least


1cm of expansion is required in order to minimize the
number of surgical procedures. Undue or excessive
expansion can cause neurologic complications.

Expansion Conversion Table


Expansion # of Turns

0.5cm 5

1.0cm 11

1.5cm 17

2.0cm 22

31
Distal Femoral Growing Prosthesis
Surgical Protocol

Lock the Prosthesis

> Once the prosthesis has been expanded to the desired


Clockwise length, lock the prosthesis again by re-inserting the
smaller hex screwdriver into the same hole used to
unlock the prosthesis and turn clock-wise (Figure 38).
An audible click from the locking screwdriver handle
will indicate that the device is locked. Do not bend the
screwdriver. Ensure that the smaller hex screwdriver is
fully seated in the hole prior to locking the device.

Appendix II: Taper Disassembly


Figure 38
> Should it be necessary to disengage an assembled taper
joint, a taper separator is provided. The taper separator
utilizes the mechanical advantage of a wedge(s) and
lever arm to overcome the locking forces of the tapers
and separate the components. It is important that
the separator be positioned so that the wedge(s) does
not act against the anti-rotation tabs of the implants.
The correct orientation is in an anterior-to-posterior
direction. The implants are designed to withstand the
forces generated by the separator in this direction.
Placement of the separator wedges against the anti-
rotation tabs may damage them, making disengagement
difficult. The separator may be used via three different
methods.

Figure 39
Method 1
> The wedges are initially advanced by hand to bring
them in contact with the implant at the joint to be
disengaged. The wedges are advanced by turning the
Figure 40 nut in a clockwise direction, until resistance is felt
(Figure 39). The wedges are then further advanced,
using the wrench end of the 5-in-1 impactor provided,
until the tapers disengage.
Method 2
> The wedges of the separator are advanced until they are Method 3
sufficiently tight against the taper junction to be separated
using the wrench end of the 5-in-1 impactor. A mallet > The separator can be disassembled and the chisel
can then be used to impact the chisel component of the component of the assembly can be used by itself to
separator. The separator is designed to allow the nut and separate a taper junction (Figure 40). The chisel is
chisel to travel a small distance when impacted to ease inserted anteriorly at the location to be separated and
separation. impacted with a mallet until separation is achieved.
Caution should be taken when disengaging any taper-
locked joint. The high forces that hold a taper-locked
32 joint together may result in a sudden and forceful action
upon disengagement along the axis of the tapers.
Instrument Bar

Appendix III: Growing Prosthesis 6497-2-300


Sterilization Instructions 2mm Hex Screwdriver for Distal Femoral
Growing Prosthesis

> To sterilize the Growing Prosthesis (using a Pressure/


Vacuum Sterilizer):

• Device must be double wrapped, using steam


6496-9-054/055/056
sterilization compatible pouches or wrap
Taper Separator - Assembly
(i.e.: blue wrap).

• Adequate monitoring of the sterilization cycle


is required:
Chemical Monitor: Class 6 integratorBiological 6496-9-063
Monitor: Biological indicator (BI) Challenge Test 5-In-1 Impactor/Wrench
Pack (16 towel test pack per AAMI)

> Parameters for sterilization

• Method: Moist Heat

• Cycle: Pre-Vacuum (Pre-Vac)

• Temperature: 132°C (270°F)(minimum)

• Time: 20 minutes (minimum)

• Dry Time: 30 minutes (in chamber)

• Cooling: 30 minutes (room temperature)


(as required)

> After sterilization, inspect sterilization pouches/wraps


prior to use for any breaches, residual moisture, or
particulate contamination. If particulate contamination
is evident, the implant must be deemed contaminated
and shall not be used. In the event of contamination,
the product must be discarded. If a breach of a pouch/
wrap and/or moisture is evident, the implant can
be resterilized using the above parameters (with an
increased drying time for residual moisture).

> Device must be implanted within seven (7) days after


sterilization. If held for more than seven (7) days,
resterilization is required.

> Prior to immediate use, the implant shall be aseptically


removed from the sterilization pouches/wraps.

> Stryker Orthopaedics has validated the above


recommended sterilization cycle. Other sterilization
methods and cycles may also be suitable. However,
individuals or hospitals are advised to validate
whichever method they deem appropriate at their
institution.

> EtO sterilization and cold sterilization techniques are


not recommended.

33
Distal Femoral Growing Prosthesis
Surgical Protocol

Catalog # Description GMRS Kit Number

Growing Prosthesis Instrument Part Numbers


6496-9-069 Distal Femoral Template 1A
6496-9-071 MRH/All Poly Tibial Template 1A
6496-9-208 8mm Facing Reamer 4A
6496-9-209 9mm Facing Reamer 4A
6496-9-210 10mm Facing Reamer 4A
6496-9-211 11mm Facing Reamer 4A
6496-9-213 13mm Facing Reamer 4A
6496-9-215 15mm Facing Reamer 4A
6496-9-217 17mm Facing Reamer 4A
8000-1040 EM Tibial Ankle Clamp 8A
8000-1056 Spiked Proximal Rod 8A
6496-9-051 Tibial Cutting Block - LEFT 8A
6496-9-052 Tibial Cutting Block - RIGHT 8A
6496-9-068 Tibial Stylus 8A
7650-1072 Tibial Stylus N/A
7650-1035 Headless Pin Driver 8A
7650-1038 Headless Pins 8A
6633-7-250 Alignment Handle 8B
6838-7-220 Short Alignment Pin 8B
6838-7-230 Long Alignment Pin 8B
6633-7-605 Pin Puller 8B
6737-8-505 Pediatric Tibial Template PT1 8B
6737-8-500 Pediatric Tibial Template PT2 8B
6633-7-610 Headed Nail Impactor Extractor 8B
6633-7-600 Headed Nails 1.5" 8A
6633-7-615 Headed Nails 0.75" 8A
6737-8-510 Pediatric Stem Drill 8B
8000-7845 Counter Sink Drill 8B
6496-2-010 Distal Femoral Trial - SMALL LEFT 1A
6496-2-020 Distal Femoral Trial - SMALL RIGHT 1A
6496-6-030 30mm Trial Extension Piece 1A
6496-6-040 40mm Trial Extension Piece 1A
6496-6-050 50mm Trial Extension Piece 1A
6496-6-060 60mm Trial Extension Piece 1A
6496-6-070 70mm Trial Extension Piece 1A
6496-6-080 80mm Trial Extension Piece 1A
6496-6-100 100mm Trial Extension Piece 1B
6496-6-120 120mm Trial Extension Piece 1B
6496-6-140 140mm Trial Extension Piece 1B
6496-6-160 160mm Trial Extension Piece 1B
6496-6-180 180mm Trial Extension Piece 1B
6496-6-200 200mm Trial Extension Piece 1B
6496-6-220 220mm Trial Extension Piece 1B

34
Catalog # Description GMRS Kit Number

Growing Prosthesis Instrument Part Numbers (Continued)


6486-3-018 8mm Cemented Stem Trial Straight - 102mm 4A
6486-3-019 9mm Cemented Stem Trial Straight - 102mm 4A
6486-3-010 10mm Cemented Stem Trial Straight - 102mm 4A
6486-3-111 11mm Cemented Stem Trial Straight - 127mm 4A
6486-3-113 13mm Cemented Stem Trial Straight - 127mm 4A
6486-3-115 15mm Cemented Stem Trial Straight - 127mm 4A
6486-3-117 17mm Cemented Stem Trial Straight - 127mm 4A
6486-3-318 8mm Cemented Stem Trial Bowed - 102mm 4B
6486-3-319 9mm Cemented Stem Trial Bowed - 102mm 4B
6486-3-310 10mm Cemented Stem Trial Bowed - 102mm 4B
6486-3-811 11mm Cemented Stem Trial Bowed - 127mm 4B
6486-3-813 13mm Cemented Stem Trial Bowed - 127mm 4B
6486-3-815 15mm Cemented Stem Trial Bowed - 127mm 4B
6486-3-817 17mm Cemented Stem Trial Bowed - 127mm 4B
6486-3-611 11mm Cemented Stem Trial Bowed - 203mm 4B
6486-3-613 13mm Cemented Stem Trial Bowed - 203mm 4B
6486-3-615 15mm Cemented Stem Trial Bowed - 203mm 4B
6486-3-617 17mm Cemented Stem Trial Bowed - 203mm 4B
6486-8-004 Trial Pediatric All Poly Tibia 8mm - PT1 7B
6486-8-005 Trial Pediatric All Poly Tibia 11mm - PT1 7B
6486-8-006 Trial Pediatric All Poly Tibia 8mm - PT2 7B
6486-8-007 Trial Pediatric All Poly Tibia 11mm - PT2 7B
6481-4-107 Trial Tibial Bearing Component - Pediatric 7B
6496-2-115 Trial Axle 1A
6496-2-130 Neutral Trial Bumper 1A
6496-2-133 3 Degree Trial Bumper 1A
6496-9-053 Impaction Tube 4A
6496-9-065 Impaction Insert - 7-11mm 4A
6496-9-066 Impaction Insert - 13-17mm 4A
9469-9-063 5-IN-1 Impactor/Wrench 3
6496-9-064 Impaction Support Block 1A
6496-9-054 Taper Separator - Body 3
6496-9-055 Taper Separator - Nut 3
6496-9-056 Taper Separateor - Chisel 3
702429 Teardrop Handle Large w/AO Quick Fitting N/A
1806-0292 Screwdriver Shaft, 3.5 x 85mm N/A
6497-2-300 2mm Hex Screwdriver for Distal Femoral Growing Prosthesis N/A

35
Distal Femoral Growing Prosthesis
Surgical Protocol

Catalog # Description

Growing Prosthesis Implant Part Numbers


6497-1-150 Distal Femoral Growing Prosthesis, Left 150mm
6497-1-160 Distal Femoral Growing Prosthesis, Left 160mm
6497-1-170 Distal Femoral Growing Prosthesis, Left 170mm
6497-1-180 Distal Femoral Growing Prosthesis, Left 180mm
6497-1-190 Distal Femoral Growing Prosthesis, Left 190mm
6497-1-200 Distal Femoral Growing Prosthesis, Left 200mm
6497-1-550 Distal Femoral Growing Prosthesis, Right 150mm
6497-1-560 Distal Femoral Growing Prosthesis, Right 160mm
6497-1-570 Distal Femoral Growing Prosthesis, Right 170mm
6497-1-580 Distal Femoral Growing Prosthesis, Right 180mm
6497-1-590 Distal Femoral Growing Prosthesis, Right 190mm
6497-1-600 Distal Femoral Growing Prosthesis, Right 200mm
6366-9-220 Axis
6466-9-230 Circlip
6465-6-018 Bearing
6465-6-007 Wedge
6497-2-301 Tibial Bearing Cmpt - Distal Femoral Growing to Pediatric All-Poly Tibia
6497-2-302 Tibial Bearing Cmpt - Distal Femoral Growing to MRH Keel Tibial Baseplate
6497-2-303 Tibial Bearing Cmpt - Distal Femoral Growing to GMRS Small Proximal Tibia
6495-6-030 Extension Piece - 30mm
6495-6-040 Extension Piece - 40mm
6495-6-050 Extension Piece - 50mm
6495-6-060 Extension Piece - 60mm
6495-6-070 Extension Piece - 70mm
6495-6-080 Extension Piece - 80mm
6495-6-100 Extension Piece - 100mm
6495-6-120 Extension Piece - 120mm
6495-6-140 Extension Piece - 140mm
6495-6-160 Extension Piece - 160mm
6495-6-180 Extension Piece - 180mm
6495-6-200 Extension Piece - 200mm
6495-6-220 Extension Piece - 220mm

36
Catalog # Description

Growing Prosthesis Implant Part Numbers (Continued)


6485-3-008 Cemented Stem with Porous Coated Body Section, 8mm
6485-3-009 Cemented Stem with Porous Coated Body Section, 9mm
6485-3-000 Cemented Stem with Porous Coated Body Section, 10mm
6485-3-011 Cemented Stem with Porous Coated Body Section, 11mm
6485-3-013 Cemented Stem with Porous Coated Body Section, 13mm
6485-3-015 Cemented Stem with Porous Coated Body Section, 15mm
6485-3-017 Cemented Stem with Porous Coated Body Section, 17mm
6485-3-018 Cemented Stem without Porous Coated Body Section, 8mm
6485-3-019 Cemented Stem without Porous Coated Body Section, 9mm
6485-3-010 Cemented Stem without Porous Coated Body Section, 10mm
6485-3-111 Cemented Stem without Porous Coated Body Section, 11mm
6485-3-113 Cemented Stem without Porous Coated Body Section, 13mm
6485-3-115 Cemented Stem without Porous Coated Body Section, 15mm
6485-3-117 Cemented Stem without Porous Coated Body Section, 17mm
6485-3-308 Cemented Curved Stem with Porous Coated Body Section, 8mm
6485-3-309 Cemented Curved Stem with Porous Coated Body Section, 9mm
6485-3-300 Cemented Curved Stem with Porous Coated Body Section, 10mm
6485-3-711 Cemented Curved Stem with Porous Coated Body Section, 11mm
6485-3-713 Cemented Curved Stem with Porous Coated Body Section, 13mm
6485-3-715 Cemented Curved Stem with Porous Coated Body Section, 15mm
6485-3-717 Cemented Curved Stem with Porous Coated Body Section, 17mm
6485-3-318 Cemented Curved Stem without Porous Coated Body Section, 8mm
6485-3-019 Cemented Curved Stem without Porous Coated Body Section, 9mm
6485-3-310 Cemented Curved Stem without Porous Coated Body Section, 10mm
6485-3-811 Cemented Curved Stem without Porous Coated Body Section, 11mm
6485-3-813 Cemented Curved Stem without Porous Coated Body Section, 13mm
6485-3-815 Cemented Curved Stem without Porous Coated Body Section, 15mm
6485-3-817 Cemented Curved Stem without Porous Coated Body Section, 17mm
6485-3-311 Cemented Long Curved Stem with Porous Coated Body Section, 11mm
6485-3-313 Cemented Long Curved Stem with Porous Coated Body Section, 13mm
6485-3-315 Cemented Long Curved Stem with Porous Coated Body Section, 15mm
6485-3-317 Cemented Long Curved Stem with Porous Coated Body Section, 17mm
6485-3-611 Cemented Long Curved Stem without Porous Coated Body Section, 11mm
6485-3-613 Cemented Long Curved Stem without Porous Coated Body Section, 13mm
6485-3-615 Cemented Long Curved Stem without Porous Coated Body Section, 15mm
6485-3-617 Cemented Long Curved Stem without Porous Coated Body Section, 17mm

37
Distal Femoral Growing Prosthesis
Surgical Protocol

Catalog # Description

Growing Prosthesis Implant Part Numbers (Continued)


6485-2-508 Pediatric All Poly Tibia - PT1, 8mm
6485-2-511 Pediatric All Poly Tibia - PT1, 11mm
6485-2-608 Pediatric All Poly Tibia - PT2, 8mm
6485-2-611 Pediatric All Poly Tibia - PT2, 11mm
6481-3-210 MRH Tibial Insert - S1/S2, 10mm
6481-3-213 MRH Tibial Insert - S1/S2, 13mm
6481-3-216 MRH Tibial Insert - S1/S2, 16mm
6481-3-220 MRH Tibial Insert - S1/S2, 20mm
6481-3-224 MRH Tibial Insert - S1/S2, 24mm
6481-3-310 MRH Tibial Insert - M2/L2, 10mm
6481-3-313 MRH Tibial Insert - M2/L2, 13mm
6481-3-316 MRH Tibial Insert - M2/L2, 16mm
6481-3-320 MRH Tibial Insert - M2/L2, 20mm
6481-3-324 MRH Tibial Insert - M2/L2, 24mm
6481-3-110 MRH Keel Tibial Baseplate - S1
6481-3-111 MRH Keel Tibial Baseplate - S2
6481-3-112 MRH Keel Tibial Baseplate - M2
6481-3-113 MRH Keel Tibial Baseplate - L2
6476-8-260 Cemented Stem Extender - 80mm
6476-8-270 Cemented Stem Extender - 155mm
6478-6-395 Cobalt Chrome Stem - 80mm x 10mm
6478-6-396 Cobalt Chrome Stem - 80mm x 11mm
6478-6-397 Cobalt Chrome Stem - 80mm x 12mm
6478-6-398 Cobalt Chrome Stem - 80mm x 13mm
6478-6-399 Cobalt Chrome Stem - 80mm x 14mm
6478-6-400 Cobalt Chrome Stem - 80mm x 15mm
6478-6-405 Cobalt Chrome Stem - 80mm x 16mm
6478-6-410 Cobalt Chrome Stem - 80mm x 17mm
6478-6-415 Cobalt Chrome Stem - 80mm x 18mm
6478-6-420 Cobalt Chrome Stem - 80mm x 19mm
6478-6-425 Cobalt Chrome Stem - 80mm x 21mm
6478-6-430 Cobalt Chrome Stem - 80mm x 23mm
6478-6-435 Cobalt Chrome Stem - 155mm x 10mm
6478-6-436 Cobalt Chrome Stem - 155mm x 11mm
6478-6-437 Cobalt Chrome Stem - 155mm x 12mm
6478-6-438 Cobalt Chrome Stem - 155mm x 13mm
6478-6-439 Cobalt Chrome Stem - 155mm x 14mm
6478-6-440 Cobalt Chrome Stem - 155mm x 15mm
6478-6-445 Cobalt Chrome Stem - 155mm x 16mm
6478-6-450 Cobalt Chrome Stem - 155mm x 17mm
6478-6-455 Cobalt Chrome Stem - 155mm x 18mm
6478-6-460 Cobalt Chrome Stem - 155mm x 19mm
6478-6-465 Cobalt Chrome Stem - 155mm x 21mm
6478-6-470 Cobalt Chrome Stem - 155mm x 23mm

38
Catalog # Description

Growing Prosthesis Implant Part Numbers (Continued)


6478-6-600 Titanium Fluted Stem - 80mm x 10mm
6497-6-605 Titanium Fluted Stem - 80mm x 11mm
6478-6-610 Titanium Fluted Stem - 80mm x 12mm
6478-6-615 Titanium Fluted Stem - 80mm x 13mm
6478-6-620 Titanium Fluted Stem - 80mm x 14mm
6478-6-625 Titanium Fluted Stem - 80mm x 15mm
6478-6-630 Titanium Fluted Stem - 80mm x 16mm
6478-6-635 Titanium Fluted Stemr - 80mm x 17mm
6478-6-640 Titanium Fluted Stem - 80mm x 18mm
6478-6-645 Titanium Fluted Stem - 80mm x 19mm
6478-6-655 Titanium Fluted Stem - 80mm x 21mm
6478-6-665 Titanium Fluted Stem - 80mm x 23mm
6478-6-680 Titanium Fluted Stem - 155mm x 10mm
6478-6-685 Titanium Fluted Stem - 155mm x 11mm
6478-6-690 Titanium Fluted Stem - 155mm x 12mm
6478-6-695 Titanium Fluted Stem - 155mm x 13mm
6478-6-705 Titanium Fluted Stem - 155mm x 14mm
6478-6-710 Titanium Fluted Stem - 155mm x 15mm
6478-6-715 Titanium Fluted Stem - 155mm x 16mm
6478-6-720 Titanium Fluted Stem - 155mm x 17mm
6478-6-725 Titanium Fluted Stem - 155mm x 18mm
6478-6-730 Titanium Fluted Stem - 155mm x 19mm
6478-6-730 Titanium Fluted Stem - 155mm x 21mm
6478-6-750 Titanium Fluted Stem - 155mm x 23mm
6495-3-101 Proximal Tibial Component - Small
6495-3-010 GMRS Tibial Insert for Small Proximal Tibia - 10mm
6495-3-013 GMRS Tibial Insert for Small Proximal Tibia - 13mm
6495-3-016 GMRS Tibial Insert for Small Proximal Tibia - 16mm
6495-3-020 GMRS Tibial Insert for Small Proximal Tibia - 20mm
6495-3-024 GMRS Tibial Insert for Small Proximal Tibia - 24mm

39
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Mahwah, NJ 07430
t: 201 831 5000
[Link]

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to
use a particular product when treating a particular patient. Stryker does not dispense medical advice and
recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings.
A surgeon must always refer to the package insert, product label and/or instructions for use before using
any Stryker product. Products may not be available in all markets because product availability is subject to
the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if
you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for
the following trademarks or service marks: Duration, GMRS, Stryker, V40. All other trademarks are
trademarks of their respective owners or holders.

GMRS-SP-1
MS/GS 11/13

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