Surgical Technique

Perimeter ™

Interbody Fusion Device

with Catalyst™ Anterior Instrument Set
and Infuse™ Bone Graft
 Table of Contents

3 Implant Overview
5 Introduction
6 Instrument Set
8 Distraction and Trialing
9 Bone Graft Preparation and Placement
10 End Plate Preparation
11 Catalyst™ Assembly
19 Direct Anterior Implant Insertion
21 Additional Insertion Options
22 Stabilization and Explantation
23 Preparation Instructions for Infuse™ Bone Graft
29 Set Configurations
31 Infuse™ Bone Graft Kit Components

1
32 Fill Guidelines
33 Summary of Important Product Information

Distract

2
Deliver

3
Remove

All in One
Step
2
Implant Overview

Anatomical Shape
• Convex
 shape to contact the vertebral body end
plates
A
• A
 natomic shape of the implant designed to allow
contact with the vertebral body end plates
Axial View
• Implant available in 4°, 8° and 12° lordotic angles
• M
 ultiple attachment points to allow for direct
anterior, anterolateral, and direct lateral insertions
B

A/P View

Perimeter™ Interbody Markers are approximately 3mm

Fusion Device long. Measurements are taken from
the center of the marker.

A. B. C. D.
Distance from Distance from Distance from Distance from
Medial Anterior Degree Marker to Marker to Marker to Lateral Edge to
to Lateral to Posterior of Lordosis Posterior Edge Anterior Edge Lateral Edge Center Marker

Small 19mm × 15mm 4° 1.5mm 1.5mm 3.5mm 9.5mm

Medium 26mm × 21mm 8° 2.0mm 2.0mm 6.0mm 13.0mm

Large 30mm × 24mm 8° and 12° 2.0mm 2.0mm 6.0mm 15.0mm

XL 36mm × 28mm 8° 3.0mm 3.0mm 7.0mm 18.0mm

Note
The hollow geometry of the implants allows them to be packed with either autogenous bone graft or Infuse™
bone graft.
When used with Infuse™ bone graft, the device may be implanted at a single level using an Anterior Lumbar
Interbody Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an
Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1.
Importantly, only certain sizes of the PEEK Perimeter™ interbody fusion device are approved for use with Infuse™
bone graft. Consult page 31 of this surgical technique or the labeling for the Infuse™ bone graft/Medtronic
interbody fusion device for approved PEEK implant sizes.

3
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Implant Overview

Aggressive Surface
• Reverse-angled teeth help resist push-out
• Teeth aid in securing the implant to the bone

Open Design
• Open design for autogenous graft or Infuse™ bone graft

Risks
• B
 one fracture or stress shielding at, above, or below
the level of surgery.
• Loss of or increase in spinal mobility or function.
• Implant migration.
• L
 oss of proper spinal curvature, correction, height,
and/or reduction.
• Bone graft donor site complication.

PEEK Material
Radiolucent for visualization of bone growth
• Biocompatible material — long medical use history:
- Dental implants - Heart valves
- Artificial joints - Finger implants
- Spinal implants
• Strength
- Offers high impact resistance
• Modulus of Elasticity (MOE)
- MOE between that of cortical and cancellous bone
- Load-sharing similar to bone

4
Introduction

Perimeter™ Interbody Fusion Device with Catalyst™

Anterior Instrument Set for Impacted ALIF Procedures
• Instruments are narrower than the implant, which allows for
desirable visibility and smaller incisions.
• Insert and rotate distractors are provided for use in
initial distraction.
• D
 ouble-sided broaches allow end-plate preparation for
corresponding implant placement.
• D
 elivery instrument distracts, delivers, and removes all in one
step.
• T
 he implant is advanced via a threaded mechanism as the
blades provide distraction, causing no impaction stresses on
the implant.
• Straight and oblique approaches are available.
• The Catalyst™ anterior instrument set can be used to insert
Medtronic’s Perimeter™ implants, Sovereign™ implants, and
Precision-Graft™ implants.

1
Distract

2
Deliver

3
Remove

5
Instrument Set

3289008

3289010

3289012

3289014

3289016

3289018

3289020

Distractors
8mm, 10mm, 12mm, 14mm, 16mm, 18mm and 20mm

Broach Tips 26mm Graft Tamp

8mm, 10mm, 12mm, 14mm, 16mm, (3289003)
18mm and 20mm
(3289208, 3289210, 3289212,
3289214, 3289216, 3289218, 3289220)

Broach Handle
(3289002)

T-Handle Inserter Handle

(2900164) (3289400)

6
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Instrument Set

Blades Hammer/Slap Hammer

Straight (3289610, 3289611) and (3289001)
Oblique (3289612, 3289613)

Spreader Blocks Countersink Adapter

8mm, 10mm, 12mm, 14mm, 16mm, +3mm and +6mm
18mm and 20mm Straight (3289413, 3289416) and
Straight (3289708, 3289710, 3289712, Oblique bone (3289423, 3289426)
3289714, 3289716, 3289718, 3289720)
and Oblique (3289808, 3289810, 3289812,
3289814, 3289816, 3289818, 3289820)

Inserter Shaft
(3289401)

Implant Shaft
Bone (3289403) and Mesh (3289404)

Perimeter™ Inserter Outer Sleeve

(3499002)

Perimeter™ Inserter Inner Shaft

(3499001)

7
Distraction and Trialing

Sequentially distract the disc space using the distractors

and quick-connect T-handle while removing the disc
and preparing the end plates (Figure 1). Next, use the
trial and trial handles to confirm the correct height and
footprint size of implant (Figure 2).

Figure 1

Figure 2

8
Bone Graft Preparation and Placement

Perimeter™ interbody fusion device may be used

with Infuse™ bone graft or autogenous bone graft.

If using Infuse™ bone graft:

• A
 n appropriate amount of Infuse™ bone graft
should be used according to the internal volume
of the Perimeter™ interbody fusion device. Refer
to the Table on page 31 for the appropriate kit(s)
to be used with the corresponding Perimeter™
interbody fusion device.
•A
 t this time, prepare the appropriate Infuse™ Figure 3
bone graft kit(s). Refer to pages 22-27 for
preparation instructions.
•F
 ollowing a minimum of 15 minutes, and no
more than 2 hours, use forceps to roll the wetted
collagen sponge(s) and place in the implant’s
central cavity (Figure 3).

Helpful Tip
If desired, a resorbable polyglactic 910 suture
(e.g. VICRYL™* suture) may be wrapped around the
exterior of the implant to secure Infuse™ bone graft
during implantation.

If autogenous bone graft is used instead of Infuse™

bone graft, place the autograft in the implant’s
central cavity.

9
End Plate Preparation

Connect and tighten the broach handle to the broach

(Figure 4). Using the slap hammer, sequentially broach the
end plates to the appropriate size (Figure 5). The implant
will provide a 1mm interference fit after broaching.

Figure 4

Figure 5

10
Catalyst™ Assembly Instructions

How To Assemble The Catalyst™ Anterior Instrument

1. Thread the inserter handle (3289400) onto the inserter shaft
(3289401). Inserter handle blue handle goes on first. Don’t
thread too far at first (Figures 6, 7 and 8).

Figure 6

Figure 7

Figure 8

11
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Catalyst™ Assembly Instructions

How To Assemble The Catalyst™ Anterior Instrument continued

2.  Attach the appropriate size spreader block to
the bottom of the inserter shaft. Bottom side
of spreader block goes on the bottom tip of
inserter shaft and snaps into place (Figures 9
and 10).

Figure 9

Figure 10

12
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Catalyst™ Assembly Instructions

How To Assemble The Catalyst™ Anterior Instrument continued

3. Insert the implant shaft (MESH 3289404) using the
threaded end first into the hole in the T-Handle portion
of the inserter shaft. Turn clockwise until implant shaft
threads through and cannot fall out. Threaded tip should
come through the top of the spreader block (Figures 11,
12, 13 and 14).

Figure 11 Figure 12

Figure 13 Figure 14

13
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Catalyst™ Assembly Instructions

How To Assemble The Catalyst™ Anterior Instrument continued

4. If you choose to countersink, take the appropriate
countersink adapter and slide onto the spreader
block (Figure 15). Countersink adapter prongs should
interface directly with and slide onto the spreader
block channels (Figure 16). (+6mm countersink
adapter shown)

Figure 15

Figure 16

14
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Catalyst™ Assembly Instructions

How To Assemble The Catalyst™ Anterior Instrument continued

5. Take the appropriate size Perimeter™ device and thread
onto the implant shaft threaded tip (Figures 17 and 18).

Figure 17 Figure 18

6. Align the spreader block protrusions to where

they line up with the inserter handle notches
(Figure 19).

Figure 19

15
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Catalyst™ Assembly Instructions

How To Assemble The Catalyst™ Anterior Instrument continued

7. Take the appropriate bottom blade and load onto
the inserter handle notch with the depth stop facing
down. Move the bottom blade upward to lock into the
inserter handle notch. Bottom blade must align with the
spreader block protrusion (Figures 20, 21 and 22).

Figure 20

Figure 21

Figure 22

16
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Catalyst™ Assembly Instructions

How To Assemble The Catalyst™ Anterior Instrument continued

8. Turn the T-Handle clockwise until the spreader block
protrusion extends out of and continues down the
bottom blade open slot into the narrow channel, locking
the bottom blade into place (Figure 23).

Figure 23

9. Take the appropriate top blade and load onto the

inserter handle notch with the depth stop facing down.
Move the top blade upward to lock into the inserter
handle notch. Top blade must align with the spreader
block protrusion (Figure 24).

Figure 24

17
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Catalyst™ Assembly Instructions

How To Assemble The Catalyst™ Anterior Instrument continued

10. Keeping the instrument level with the top blade facing
up (depth stop up), turn the T-Handle clockwise until
the spreader block protrusion extends out of and
continues down the top blade open slot into the
narrow channel (Figures 25 and 26).

Figure 25

Figure 26

11. The Catalyst™ instrument is ready for use.

18
Direct Anterior Implant Insertion

With the implant loaded into the inserter, place the tip the instrument will provide the distraction required for
of the blades into the disc space until the depth stops insertion. Continue to turn the T-handle until the depth
contact the vertebral bodies (Figures 27 and 28). Turn stops of the spreader contact the vertebral body
the T-handle to drive the implant down the blades into (Figure 30). The implant is now positioned at the
the disc space (Figure 29). As the implant advances, appropriate countersink depth.

Figure 27 Figure 28

Figure 29 Figure 30

19
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Direct Anterior Implant Insertion

While maintaining downward pressure on the inserter handle (to keep the blade depth stops in contact with
the vertebral bodies), continue to rotate the T-handle to withdraw the blade tips from the disc space (Figure 31).
Disconnect the Inserter by unscrewing the shaft from the implant (Figure 32). The inserter can now be removed
from the surgical site (Figure 33).

Figure 31

Figure 32 Figure 33

20
Additional Insertion Options

How to Assemble the Perimeter™ Inserter

Inserter and Implant Assembly:

1. Insert inner shaft (w/knob) (3499001) into outer sleeve

(3499002).
2. Turn knob on inner shaft (3499001), clockwise†, until fully
seated against the outer sleeve (3499002).
3. Once inserter is assembled, implant can be threaded
onto inner shaft by placing the anterior section of
the implant with threaded hole on to the end of the
threaded end of the shaft and turning the knob opposite
the threads clockwise. Continue to turn knob until
implant is fully secured to outer sleeve (3499002). It
takes approximately 6 or more turns to fully secure
implant to inserter
†
It takes approximately 8 turns to fully assemble the inserter.

Anteriolateral Insertion Option Using the Catalyst™ Inserter

At levels L5-L4 and above, it may be necessary to insert Once the Catalyst™ inserter is assembled with the
the implant using an anteriolateral approach. This oblique blades, attach the inserter to the Perimeter™
can be accomplished by loading the implant on either device using one of the oblique holes. There are two
the Catalyst™ inserter or the implant inserter from the options to choose from, 30° or 45°. Once the implant
Perimeter™ instrument set. is loaded onto the inserter, place the tip of the blades
into the disc space until the depth stop makes contact
Direct Lateral Insertion Option with the vertebral bodies. Turn the T-handle to drive
When a direct lateral insertion of the Perimeter™ the implant down the blades into the disc space. As
device is required, attach the implant to the Perimeter™ the implant advances, the instrument will provide the
inserter. Once the approach is made and the distraction required for insertion.
discectomy and end-plate preparation is complete, Note
insert the appropriately sized implant. Maintain downward pressure on the inserter
Attach the Perimeter™ device using one of the lateral while advancing the graft.
holes on the Perimeter™ inserter. This is accomplished Continue to turn the T-handle until the depth stops of
by threading the implant shaft into the implant hole and the spreader contact the vertebral body. The implant is
tightening by using the thumbwheel at the end of the now positioned at the appropriate countersink depth.
instrument. Once the implant is securely attached to the
inserter, use a mallet to impact the implant into the disc While maintaining downward pressure on the inserter
space. Once the implant is placed centrally in the disc handle to keep the blade depth stops in contact with
space, detach the implant from the inserter using the the vertebral bodies, continue to rotate the T-handle
thumbwheel. The inserter can now be removed from to withdraw the blade tips from the disc space. Once
the surgical site. the blades are removed, disconnect the inserter by
unscrewing the implant shaft from the implant using
the thumbwheel on the T-handle. The inserter can now
be removed from the surgical site.
This can also be accomplished by attaching to the
Perimeter™ inserter and impacting the implant into
place.
21
Stabilization and Explantation

Apply anterior and/or posterior supplemental fixation such

as the Pyramid™ +4 anterior lumbar plate system 3-hole
lordotic plate or the CD Horizon™ Sextant™ percutaneous
rod system for additional fixation.

Pyramid™ +4 Anterior Lumbar Plate System CD Horizon™ Sextant™ Percutaneous Rod System
3-Hole Lordotic Plate

Explantation
If it becomes necessary to remove the implant, attach it
to the Inserter to extract it. If bone has grown through
the implant, it may be necessary to use an osteotome to
remove bone between the end plates and the implant.

22
Preparation Instructions
for Infuse™ Bone Graft Component

7510050 XX Small Kit (0.7cc)

Note: You will need to prepare a sterile and non-

sterile field before beginning product preparation.
(1) 10mL vial (1) 1.05mg (1) ACS ½" × 2"
Total preparation time: Allow at least 15 minutes for vial (1.25cm × 5.08cm)
preparation and an additional 15 minutes for protein 0.7cc graft volume
to bind to collagen sponge.

In non-sterile field

1 2 0.9mL 3 0.9mL 4

Observing proper Using one needle and Reconstitute the Gently swirl (do not
sterile technique, open 3mL syringe/needle, rhBMP-2 with 0.9mL shake) the rhBMP‑2 vial
the outer Absorbable withdraw 0.9mL of sterile water. to ensure adequate
Collagen Sponge (ACS) of sterile water for mixing. Inspect the
package and place the injection. solution. If dark
inner package containing particles are observed,
the one ½" × 2" collagen do not use and return
sponge in the sterile to sponsor.
field. Open and place
one of the two 3mL
syringe/needles in the
sterile field.

In sterile field

5 6 7 0.7mL
on ACS

Open the inner In the sterile field Uniformly distribute

ACS package use the 3mL syringe/ 0.7mL of reconstituted
leaving the needle to withdraw rhBMP-2 on the ½" × 2"
collagen sponge in 0.7mL of reconstituted collagen sponge.
the plastic tray. rhBMP‑2 from the vial Inspect the sponge.
held by the person in If dark particles are
the non-sterile field. observed, do not use
and return to sponsor.

Allow wetted collagen sponges to stand for a minimum of 15 minutes. Use within 2 hours. DO NOT use
! irrigation or suction near implanted device. Note: During handling avoid excessive squeezing of the
wetted sponge.
23
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Preparation Instructions for Infuse™ Bone Graft Component

7510100 X Small Kit (1.4cc)

Note: You will need to prepare a sterile and non-

sterile field before beginning product preparation.
(2) 10mL vial (2) 1.05mg (1) ACS 1" × 2"
Total preparation time: Allow at least 15 minutes for vial (2.5cm × 5.08cm)
preparation and an additional 15 minutes for protein 1.4cc graft volume
to bind to collagen sponge.
In non-sterile field

1 2 0.9mL 3 0.9mL 4

Observing proper Using one of the Reconstitute one vial of Gently swirl (do not
sterile technique, open two remaining 3mL the rhBMP‑2 with 0.9mL shake) the rhBMP‑2 vial
the outer Absorbable syringes/needles of sterile water. to ensure adequate
Collagen Sponge (ACS) withdraw 0.9mL mixing. Using a second
package and place the of sterile water for 3mL syringe/needle
inner package containing injection. repeat steps 2‑3 with
the one 1" × 2" collagen the remaining vial of
sponge in the sterile sterile water and vial of
field. Open and place rhBMP‑2. Inspect the
two 3mL syringes/ solution in both vials.
needles into the sterile If dark particles are
field. observed, do not use
and return to sponsor.

In sterile field

5 6 7 0.7mL on
½ ACS
8 9 0.7mL on
½ ACS

Open the inner ACS In the sterile field Uniformly distribute In the sterile field Uniformly distribute
package leaving the use the 3mL syringe/ 0.7mL of reconstituted use the second 3mL 0.7mL of reconstituted
collagen sponge in needle to withdraw rhBMP‑2 on half of syringe/needle to rhBMP‑2 on the other
the plastic tray. 0.7mL of reconstituted the 1" × 2" collagen withdraw 0.7mL half of the 1" × 2"
rhBMP‑2 from the first sponge. of reconstituted collagen sponge.
vial held by the person rhBMP‑2 from the The total amount
in the non-sterile field. second vial held by of reconstituted
the person in the non- rhBMP‑2 delivered to
sterile field. the sponge is 1.4mL.
Inspect the sponge.
If dark particles are
observed, do not use
and return to sponsor.

Allow wetted collagen sponges to stand for a minimum of 15 minutes. Use within 2 hours. DO NOT use
! irrigation or suction near implanted device. Note: During handling avoid excessive squeezing of the
wetted sponge.
24
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Preparation Instructions for Infuse™ Bone Graft Component

7510200 Small Kit (2.8cc)

Note: You will need to prepare a sterile and non-

sterile field before beginning product preparation. (1) 10mL vial (1) 4.2mg vial (2) ACS 1" × 2"
Total preparation time: Allow at least 15 minutes for (2.54cm × 5.08cm)
preparation and an additional 15 minutes for protein 2.8cc graft volume
to bind to collagen sponge.
In non-sterile field

1 2 3.2mL 3 3.2mL 4

Observing proper sterile Using the other 5mL Reconstitute the Gently swirl (do not
technique, open the outer syringe/needle, rhBMP‑2 with 3.2mL shake) the rhBMP‑2
ACS package and place the withdraw 3.2mL of sterile water. vial to ensure
inner package containing of sterile water for adequate mixing.
the two 1" × 2" collagen injection.
sponges in the sterile field.
Open and place one of the
two 5mL syringes/needles
into the sterile field.

In sterile field

5 6 7 1.4mL on
1st ACS
8 1.4mL on
2nd ACS

Open the inner ACS In the sterile Uniformly distribute Using the same 5mL
package leaving all field use the 5mL 1.4mL of reconstituted syringe/needle,
collagen sponges syringe/needle to rhBMP‑2 on one of repeat steps 6 and
in the plastic tray. withdraw 1.4mL the 1" × 2" collagen 7 for the remaining
of reconstituted sponges. 1" × 2" collagen
rhBMP‑2 from the vial sponge.
held by the person in
the non‑sterile field.

Allow wetted collagen sponges to stand for a minimum of 15 minutes. Use within 2 hours. DO NOT use
! irrigation or suction near implanted device. Note: During handling avoid excessive squeezing of the
wetted sponge.
25
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Preparation Instructions for Infuse™ Bone Graft Component

7510400 Medium Kit (5.6cc)

Note: You will need to prepare a sterile and non-
sterile field before beginning product preparation.
(2) 10mL vial (2) 4.2mg (4) ACS 1" × 2"
Total preparation time: Allow at least 15 minutes for vials (2.54cm × 5.08cm)
preparation and an additional 15 minutes for protein 5.6cc graft volume
to bind to collagen sponge.
In non-sterile field

1 2 3.2mL 3 3.2mL 4

Observing proper sterile Using one of the Reconstitute one vial Gently swirl (do not shake)
technique, open the outer ACS two remaining 5mL of the rhBMP-2 with the rhBMP‑2 vial to ensure
package and place the inner syringes/needles, 3.2mL of sterile water. adequate mixing. Using a
package containing the four withdraw 3.2mL second 5mL syringe/needle,
1" × 2" collagen sponges in the of sterile water for repeat steps 2 and 3 with
sterile field. Open and place two injection. the remaining vial of sterile
of the four 5mL syringes/needles water and vial of rhBMP-2.
into the sterile field.

In sterile field

5 6 7 1.4mL on
1st ACS
8 1.4mL on
2nd ACS

Open the inner ACS In the sterile field use the 5mL Uniformly distribute Using the same 5mL
package leaving all syringe/needle to withdraw 1.4mL of reconstituted syringe/needle, repeat
collagen sponges in the 1.4mL of reconstituted rhBMP-2 rhBMP‑2 on one of the steps 6 and 7 for the
plastic tray. from the vial held by the person 1" × 2" collagen sponges. second 1" × 2"
in the non‑sterile field. collagen sponge.

9 10 1.4mL on
3rd ACS
11 1.4mL on
4th ACS

In the sterile field use the Uniformly distribute Using the second 5mL
second 5mL syringe/needle 1.4 mL of reconstituted syringe/needle, repeat
to withdraw 1.4mL of rhBMP-2 on the third steps 9 and 10 for the
reconstituted rhBMP-2 from 1" × 2" collagen sponge. fourth 1" × 2" collagen
the second vial held by the sponge.
person in the non-sterile field.
Allow wetted collagen sponges to stand for a minimum of 15 minutes. Use within 2 hours. DO NOT use
! irrigation or suction near implanted device. Note: During handling avoid excessive squeezing of the
wetted sponge.
26
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Preparation Instructions for Infuse™ Bone Graft Component

7510600 Large Kit (8.0cc)

Note: You will need to prepare a sterile and non-

sterile field before beginning product preparation.
(1) 10mL vial (1) 12mg vial (6) ACS 1" × 2"
Total preparation time: Allow at least 15 minutes for (2.54cm × 5.08cm)
preparation and an additional 15 minutes for protein 8.0cc graft volume
to bind to collagen sponge.
In non-sterile field

1 2 8.4mL 3 8.4mL 4

Observing proper sterile Using the other 10mL Reconstitute the Gently swirl (do not shake)
technique, open the outer syringe/needle, rhBMP‑2 with 8.4mL the rhBMP‑2 vial to ensure
ACS package and place the withdraw 8.4mL of sterile water. adequate mixing.
inner package containing of sterile water for
the six 1" × 2" collagen injection.
sponges in the sterile field.
Open and place one of the
two 10mL syringes/needles
into the sterile field.

In sterile field

5 6 7 4.0mL on
1st three ACS
8 4.0mL on
2nd three ACS

Open the inner ACS In the sterile field use the 10mL Uniformly distribute Using the same 10mL
package leaving all syringe/needle to withdraw 4.0mL of reconstituted syringe/needle, repeat
collagen sponges in the 4.0mL of reconstituted rhBMP‑2 rhBMP‑2 on three of the steps 6 and 7 for the
plastic tray. from the vial held by the person 1" × 2" collagen sponges. remaining 1" × 2"
in the non‑sterile field. collagen sponges.

Allow wetted collagen sponges to stand for a minimum of 15 minutes. Use within 2 hours. DO NOT use
! irrigation or suction near implanted device. Note: During handling avoid excessive squeezing of the
wetted sponge.
27
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Preparation Instructions for Infuse™ Bone Graft Component

7510800 Large II Kit (8.0cc)

Note: You will need to prepare a sterile and non-

sterile field before beginning product preparation.
(1) 10mL vial (1) 12mg vial (1) ACS 3" × 4"
Total preparation time: Allow at least 15 minutes for (7.62cm × 10.16cm)
preparation and an additional 15 minutes for protein 8.0cc graft volume
to bind to collagen sponge.
In non-sterile field

1 2 8.4mL 3 8.4mL 4

Observing proper sterile Using the other 10mL Reconstitute the Gently swirl (do not shake)
technique, open the outer syringe/needle, rhBMP‑2 with 8.4mL the rhBMP‑2 vial to ensure
ACS package and place the withdraw 8.4mL of sterile water. adequate mixing.
inner package containing the of sterile water for
3" × 4" collagen sponge in the injection.
sterile field. Open and place
one of the two 10mL syringes/
needles into the sterile field.

In sterile field

5 6 7 4.0mL on
1st ACS
8 4.0mL on
2nd ACS

Open the inner ACS In the sterile field use the 10mL Uniformly distribute 4.0mL Using the 10mL syringe/
package. Using sterile syringe/needle to withdraw 4.0mL of reconstituted rhBMP‑2 needle, repeat steps 6 and
scissors, cut the 3" × 4" of reconstituted rhBMP-2 from on one of the 1 1/2" × 4" 7 for the remaining 1 1/2"
collagen sponge into two the vial held by the person in the collagen sponges. × 4" collagen sponge.
1 1/2" × 4" strips. Return non‑sterile field.
the cut collagen sponges
to the plastic tray.

Allow wetted collagen sponges to stand for a minimum of 15 minutes. Use within 2 hours. DO NOT use
! irrigation or suction near implanted device. Note: During handling avoid excessive squeezing of the
wetted sponge.
28
Set Types and Configurations

Perimeter™ Instrument set Perimeter™ Medium/Large Implant set

Set Type: SPS00465 Set Type: SPS02211
Part Number Description Quantity Part Number Description Quantity
3289001 Mallet 1 3492308 Perimeter™ Medium, 8mm, 8º 2
3289002 Broach Handle 2 3492310 Perimeter™ Medium, 10mm, 8º 2
3499001 Inserter Inner Shaft 1 3492312 Perimeter Medium, 12mm, 8º
™
2
3499002 Inserter Outer Sleeve 1 3492314 Perimeter™ Medium, 14mm, 8º 2
3299003 Graft Tamp 1 3492316 Perimeter™ Medium, 16mm, 8º 2
3299005 Discectomy Template 1 3492318 Perimeter™ Medium, 18mm, 8º 1
3297108 Trial, Small, 8mm, 4º 1 3492320 Perimeter™ Medium, 20mm, 8º 1
3297110 Trial, Small, 10mm, 4º 1 3493308 Perimeter™ Large, 8mm, 8º 2
3297112 Trial, Small, 12mm, 4º 1 3493310 Perimeter™ Large, 10mm, 8º 2
3297114 Trial, Small, 14mm, 4º 1 3493312 Perimeter™ Large, 12mm, 8º 2
3298108 Trial, Medium, 8mm, 8º 1 3493314 Perimeter™ Large, 14mm, 8º 2
3298110 Trial, Medium, 10mm, 8º 1 3493316 Perimeter™ Large, 16mm, 8º 2
3298112 Trial, Medium, 12mm, 8º 1 3493318 Perimeter™ Large, 18mm, 8º 1
3298114 Trial, Medium, 14mm, 8º 1 3493320 Perimeter™ Large, 20mm, 8º 1
3298116 Trial, Medium, 16mm, 8º 1 3493412 Perimeter™ Large, 12mm, 12º 2
3298118 Trial, Medium, 18mm, 8º 1 3493414 Perimeter™ Large, 14mm, 12º 2
3298120 Trial, Medium, 20mm, 8º 1 3493416 Perimeter™ Large, 16mm, 12º 2
3299108 Trial, Large, 8mm, 8º 1 3493418 Perimeter™ Large, 18mm, 12º 1
3299110 Trial, Large, 10mm, 8º 1 3493420 Perimeter Large, 20mm, 12º
™
1
3299112 Trial, Large, 12mm, 8º 1 23000000 Generic Suitcase 1
3299114 Trial, Large, 14mm, 8º 1
3299116 Trial, Large, 16mm, 8º 1
3299118 Trial, Large, 18mm, 8º 1
3299120 Trial, Large, 20mm, 8º 1
Perimeter™ XL Implant Set
3299212 Trial, Large, 12mm, 12º 1 Set Type: SPS02212
3299214 Trial, Large, 14mm, 12º 1 Part Number Description Quantity

3299216 Trial, Large, 16mm, 12º 1 3494310 Perimeter™ Extra Large, 10mm, 8º 2
3299218 Trial, Large, 18mm, 12º 1 3494312 Perimeter™ Extra Large, 12mm, 8º 2
3299220 Trial, Large, 20mm, 12º 1 3494314 Perimeter™ Extra Large, 14mm, 8º 2
3499006 Outer Case 1 3494316 Perimeter Extra Large, 16mm, 8º
™
2
3499007 Inner Tray 1 3494318 Perimeter™ Extra Large, 18mm, 8º 2
3299008 Caddy 1 3494320 Perimeter™ Extra Large, 20mm, 8º 2
3299009 Caddy Lid 1 8917656 12pc Suitcase 1
185-064 CD Horizon Base Lid Steam 1

Perimeter™ XL Trial Set

Perimeter™ Small Implant Set Set Type: SPS00466
Set Type: SPS02210 Part Number Description Quantity

Part Number Description Quantity 3290110 Trial, Extra Large, 10mm, 8º 1

3491208 Perimeter Small, 8mm, 4º
™
2 3290112 Trial, Extra Large, 12mm, 8º 1
3491210 Perimeter Small, 10mm, 4º
™
2 3290114 Trial, Extra Large, 14mm, 8º 1
3491212 Perimeter Small, 12mm, 4º
™
2 3499012 Extra Large Trial Caddy 1
3491214 Perimeter™ Small, 14mm, 4º 2 3499013 Extra Large Trial Caddy Lid 1
8917656 12pc Suitcase 1

29
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Set Types and Configurations

Catalyst™ Anterior Instrument Set

Set Type: SPS00CAT
Part Number Description Quantity
3289404 Implant Shaft, Non-Allograft (PEEK and Mesh) 1
3289403 Implant Shaft, Allograft (Tissue) 1
3289610 Straight Blade, Top 1
3289611 Straight Blade, Bottom 1
3289612 Oblique Blade, Top 1
3289613 Oblique Blade, Bottom 1
3289401 Inserter Shaft 1
3289400 Inserter Handle 1
2900164 Disctractor T-Handle 2
3289001 Slaphammer 1
3289008 8mm Distractor (Black) 1
3289010 10mm Distractor (Red) 1
3289012 12mm Distractor (Orange) 1
3289014 14mm Distractor (Yellow) 1
3289016 16mm Distractor (Green) 1
3289018 18mm Distractor (Blue) 1
3289020 20mm Distractor (White) 1
3289002 Broach/Trial Handle 2
3289208 26mm x 8mm Broach Tip (Black) 1
3289210 26mm x 10mm Broach Tip (Red) 1
3289212 26mm × 12mm Broach Tip (Orange) 1
3289214 26mm × 14mm Broach Tip (Yellow) 1
3289216 26mm × 16mm Broach Tip (Green) 1
3289218 26mm × 18mm Broach Tip (Blue) 1
3289220 26mm × 20mm Broach Tip (White) 1
3289708 8mm Spreader Block (Black) 1
3289710 10mm Spreader Block (Red) 1
3289712 12mm Spreader Block (Orange) 1
3289714 14mm Spreader Block (Yellow) 1
3289716 16mm Spreader Block (Green) 1
3289718 18mm Spreader Block (Blue) 1
3289720 20mm Spreader Block (White) 1
3289810 10mm Oblique Allograft Spreader (Red) 1
3289812 12mm Oblique Allograft Spreader (Orange) 1
3289814 14mm Oblique Allograft Spreader (Yellow) 1
3289816 16mm Oblique Allograft Spreader (Green) 1
3289818 18mm Oblique Allograft Spreader (Blue) 1
3289820 20mm Oblique Allograft Spreader (White) 1
3289413 +3mm Countersink Adapter 1
3289416 +6mm Countersink Adapter 1
3289423 +3mm Oblique Allograft Countersink Adapter 1
3289426 +6mm Oblique Allograft Countersink Adapter 1
3289003 26mm Graft Tamp 1
Caddy (Broach Tips, Spreaders, Countersink Adapters,
3289992 1
Graft Tamp)

30
Infuse™ Bone Graft Components

Infuse™ Bone Graft Components

Infuse™ Bone Graft XX Small Kit

One (1) Vial of Sterile rhBMP-2 (1.05 mg)
7510050 One (1) Package of 1 Absorbable Collagen Sponge (ACS) ½” × 2” (1.25 cm × 5 cm)
One (1) Vial of Sterile Water for Injection (10 mL)
Two (2) Sterile 3 mL Syringes with 20 G 1½” Needle

Infuse™ Bone Graft X Small Kit

Two (2) Vials of Sterile rhBMP-2 (1.05 mg)
7510100 One (1) Package of 1 Absorbable Collagen Sponge (ACS) 1” × 2” (2.5 cm × 5 cm)
Two (2) Vials of Sterile Water for Injection (10 mL)
Four (4) Sterile 3 mL Syringes with 20 G 1½” Needle

Infuse™ Bone Graft Small Kit

One (1) Vial of Sterile rhBMP-2 (4.2 mg)
7510200 One (1) Package of 2 Sterile Absorbable Collagen Sponges (ACS) 1” × 2” (2.5cm × 5cm)
One (1) Vial of Sterile Water for Injection (10 mL)
Two (2) Sterile 10 ML Syringes with 20G 1½” Needle

Infuse™ Bone Graft Medium Kit

Two (2) Vials of Sterile rhBMP-2 (4.2 mg)
7510400 One (1) Package of 4 Sterile Absorbable Collagen Sponges (ACS) 1” × 2” (2.5cm × 5cm)
Two (2) Vials of Sterile Water for Injection (10 mL)
Four (4) Sterile 10 ML Syringes with 20G 1½” Needle

Infuse™ Bone Graft Large Kit

One (1) Vial of Sterile rhBMP-2 (12 mg)
7510600 One (1) Package of 6 Sterile Absorbable Collagen Sponges (ACS) 1” × 2” (2.5cm × 5cm)
One (1) Vial of Sterile Water for Injection (10 mL)
Two (2) Sterile 10 mL Syringes with 20G 1½” Needle

Infuse™ Bone Graft Large II Kit

One (1) Vial of Sterile rhBMP-2 (12 mg)
7510800 One (1) Package of 1 Sterile Absorbable Collagen Sponge (ACS) 3” × 4” (7.6cm × 10.2cm)
One (1) Vial of Sterile Water for Injection (10 mL)
Two (2) Sterile 10 mL Syringes with 20G 1½” Needle

31
Fill Guidelines

Perimeter™ Interbody Fusion Device Infuse™ Bone Graft

Reconstituted
Part Number QTY Size (Height) Part Number(s) Kit Size(s) rhBMP-2/ACS Volume
(cc)

Medium, 8 degree
3492308 1 8mm 7510100 XS 1.4
3492310 1 10mm 7510100 XS 1.4
3492312 1 12mm 7510100+7510050 XS+XXS 2.1
3492314 1 14mm 7510200 S 2.8
3492316 1 16mm 7510200 S 2.8
3492318 1 18mm 7510200+7510050 S+XXS 3.5
3492320 1 20mm 7510200+7510050 S+XXS 3.5
Large, 8 degree
3493308 1 8mm 7510100 XS 1.4
3493310 1 10mm 7510100+7510050 XS+XXS 2.1
3493312 1 12mm 7510200 S 2.8
3493314 1 14mm 7510200 S 2.8
3493316 1 16mm 7510200+7510050 S+XXS 3.5
3493318 1 18mm 7510200+7510100 S+XS 4.2
3493320 1 20mm 7510200+7510100 S+XS 4.2
Large, 12 degree
3493412 1 12mm 7510200 S 2.8
3493414 1 14mm 7510200 S 2.8
3493416 1 16mm 7510200+7510050 S+XXS 3.5
3493418 1 18mm 7510200+7510050 S+XXS 3.5
3493420 1 20mm 7510200+7510100 S+XS 4.2
XL, 8 degree
3494310 1 10mm 7510200+7510050 S+XXS 3.5
3494312 1 12mm 7510200+7510100 S+XS 4.2
3494314 1 14mm 7510400 M 5.6
3494316 1 16mm 7510400+7510050 M+XXS 6.3
3494318 1 18mm 7510400+7510100 M+XS 7.0
3494320 1 20mm 7510600 or 7510800 L or LII 8.0

32
Summary of Important Product Information

Important Information on the Perimeter™ Interbody Fusion Device

PURPOSE CONTRAINDICATIONS
This device is a fusion device intended for stabilization use and to promote bone fusion This device is not intended for cervical spine use.
during the normal healing process following surgical correction of disorders of the spine. Contraindications include, but are not limited to:
The product should be implanted only by a physician who is thoroughly knowledgeable
in the implant’s material and surgical aspects and who has been instructed as to its • Infection local to the operative site.
mechanical and material applications and limitations. This device is manufactured • Signs of local inflammation.
in medical grade POLYETHERETHERKETONE (PEEK) or Titanium Alloy (Titanium-
• Fever or leukocytosis.
6Aluminum-4Vanadium ELI). This interbody device is provided in sterile or non-sterile
forms. Refer to the package label for sterility information. • Morbid obesity.

DESCRIPTION • Pregnancy.

The Perimeter interbody fusion device consists of cages of various widths and heights
™ • Mental illness.
which can be inserted between two lumbar or lumbosacral vertebral bodies to give • Any other condition which would preclude the potential benefit of spinal implant
support and correction during lumbar interbody fusion surgeries. The hollow geometry surgery, such as the presence of tumors or congenital abnormalities, fracture local
of the implants allows them to be packed with either autogenous bone graft or Infuse™ to the operating site, elevation of sedimentation rate unexplained by other diseases,
bone graft as designated below. The Perimeter™ interbody device is to be used with elevation of white blood count (WBC), or a marked left shift in the WBC differential
supplemental fixation instrumentation. count.
The device is offered in Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) or PEEK • Suspected or documented allergy or intolerance to composite materials.
(Polyetheretherketone). However, only the PEEK device is approved for use with Infuse™
• Any case not needing a fusion.
Bone Graft. Consult the labeling for the Infuse™ bone graft/Medtronic interbody fusion
device for approved PEEK Perimeter™ implant sizes. This interbody device is offered • Any case not described in the indications.
in sterile or non-sterile forms. Refer to the package label for specific implant sterility • Any patient unwilling to cooperate with postoperative instructions.
information.
• Patients with a known hereditary or acquired bone friability or calcification problem
The Perimeter™ interbody fusion device is offered in a variety of sizes ranging from 8mm should not be considered for this type of surgery.
to 20mm in height, 15mm to 28mm in length and between 19mm and 38mm in width.
An array of lordosis options are provided for this device spanning from 4 degrees to • Pediatric cases, nor where the patient still has general skeletal growth.
15 degrees of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum- • Spondylolisthesis unable to be reduced to Grade 1.
4Vanadium ELI) devices are designed with teeth across both the superior and inferior • Any case where the implant components selected for use would be too large or too
surfaces to allow the implant to grip the superior and inferior end plates, thus providing small to achieve a successful result.
expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4Vanadium
ELI) version of this device offers lateral windows for visibility of the autogenous bone graft. • Any case that requires the mixing of metals from two different components or systems.

Based on fatigue testing results, when using the Perimeter™ interbody fusion device, the • Any patient having inadequate tissue coverage over the operative site or inadequate
physician/surgeon should consider the levels of implantation, patient weight, patient bone stock or quality.
activity level, other patient conditions, etc., which may impact the performance of this • Any patient in which implant utilization would interfere with anatomical structures or
system. expected physiological performance.
Never use stainless steel and titanium implant components in the same • Prior fusion at the level to be treated.
construct. NOTA BENE: Although not absolute contraindications, conditions to be considered as
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium- potential factors for not using this device include:
molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or • Severe bone resorption.
medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same
construct. PEEK Optima-LT1 implants may be used with stainless steel, titanium, or cobalt- • Osteomalacia
chromium-molybdenum alloy implants. • Severe osteoporosis.
No warranties, express or implied, are made. Implied warranties of merchantability and POTENTIAL ADVERSE EVENTS
fitness for a particular purpose or use are specifically excluded.
Adverse events may occur when the device is used either with or without associated
INDICATIONS instrumentation.
The Perimeter™ interbody fusion device is indicated for interbody fusion with autogenous The potential risk of adverse events as a result of movement and non-stabilization may
bone graft in patients with degenerative disc disease (DDD) at one or two contiguous increase in cases where associated complementary support is not employed. Potential
levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis adverse events include but are not limited to:
or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with • Implant migration.
degeneration of the disc confirmed by history and radiographic studies. These patients
should be skeletally mature and have had six months of non-operative treatment. These • Breakage of the device(s).
implants may be implanted via a variety of open or minimally invasive approaches. These • Foreign body reaction to the implants including possible tumor formation, auto
approaches include anterior, lateral and oblique. These devices are intended to be used immune disease, and/or scarring.
with supplemental fixation instrumentation, which has been cleared for use in the lumbar
• Pressure on the surrounding tissues or organs.
spine.
• Damage to the peritoneum.
Certain sizes of the PEEK Perimeter™ interbody fusion device may also be used with
Infuse™ bone graft for patients diagnosed with DDD, as defined above. The device may • Loss of proper spinal curvature, correction, height, and/or reduction.
be implanted at a single level using an Anterior Lumbar Interbody Fusion (ALIF) approach • Infection.
from L2-S1. The device may also be implanted at a single level using an Oblique Lateral
Interbody Fusion (OLIF) approach from L5 to S1. The PEEK Perimeter™ interbody fusion • Bone fracture or stress shielding at, above, or below the level of surgery.
device should be used with supplemental fixation systems cleared for use in the lumbar • Non-union (or pseudoarthrosis).
spine. Consult the labeling for the Infuse™ bone graft/Medtronic interbody fusion device • Loss of neurological function, appearance of radiculopathy, dural tears, and/or
for additional information on the specific sizes of the PEEK Perimeter™ interbody fusion development of pain.
device approved for use with Infuse™ bone graft, as well as specific information regarding
contraindications, warnings, and precautions associated with Infuse™ bone graft. • Neurovascular compromise including paralysis temporary or permanent retrograde
ejaculation in males, or other types of serious injury.

33
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Summary of Important Product Information

• Cerebral spinal fluid leakage.

• Haemorrhage of blood vessels and/or hematomas.
• Damage to the anterior vasculature.
• Discitis, arachnoiditis, and/or other types of inflammation.
• Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.
• Bone graft donor site complication.
• Inability to resume activities of normal daily living.
• Early or late loosening or movement of the device(s).
• Urinary retention or loss of bladder control or other types of urological system
compromise.
• Scar formation possibly causing neurological compromise or compression around
nerves and/or pain.
• Fracture, microfracture, resorption, damage, or penetration of any spinal bone
(including the sacrum, pedicles, and/or vertebral body) and/or bone graft or bone
graft harvest site at, above, and/or below the level of surgery.
• Retropulsed graft.
• Herniated nucleus pulposus, disc disruption or degeneration at, above, or below
the level of surgery.
• Loss of or increase in spinal mobility or function.
• Reproductive system compromise including sterility, loss of consortium, and sexual
dysfunction.
• Development of respiratory problems (e.g. pulmonary embolism, atelectasis,
bronchitis, pneumonia, etc.)
• Change in mental status.
• Death.
WARNINGS AND PRECAUTIONS
A successful result is not always achieved in every surgical case. This fact is especially
true in spinal surgery where other patient conditions may compromise the results. Use
of this product without autograft or in cases that do not develop a union will not be
successful.
Preoperative and operating procedures, including knowledge of surgical techniques,
good reduction, and correct selection and placement of the implants are important
considerations in the successful utilization of the system by the surgeon. Further,
the proper selection and the compliance of the patient will greatly affect the results.
Patients who smoke have been shown to have a reduced incidence of bone fusion.
These patients should be advised of this fact and warned of this consequence. Obese,
malnourished, and/or alcohol/drug abuse patients and those with poor muscle and
bone quality and/or nerve paralysis are also poor candidates for spinal fusion.
Patients with previous spinal surgery at the levels to be treated may have different
clinical outcomes compared to those with a previous surgery.
This device was designed for single patient use only. Do not reuse, reprocess, or
resterilize this product. Reuse, reprocessing, or resterilization may compromise the
structural integrity of the device and/or create a risk of contamination of the device
which could result in patient injury, illness, or death.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the
company and the patient, the important medical information given in this document
should be conveyed to the patient.

!USA FOR US AUDIENCES ONLY

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY

OR ON THE ORDER OF A PHYSICIAN.

34
Perimeter™ Interbody Fusion Device with Catalyst™ Anterior Instrument Set Surgical Technique
Summary of Important Product Information

NOTE: The Perimeter™, Clydesdale™, Divergence-L™, and Pivox™ devices must be NOTE: The Inter Fix™ threaded fusion device and the Inter Fix™ RP Threaded Fusion
used with any supplemental fixation system cleared for use in the lumbar spine. Device may be used together to treat a spinal level. The LT-Cage™ lumbar tapered fusion
device, the Perimeter™ interbody fusion device, the Clydesdale™ spinal system, the
Divergence-L™ anterior/oblique lumbar fusion system, and the Pivox™ oblique lateral
•  In an experimental rabbit study, rhBMP-2 has been shown to elicit
spinal system implants are not to be used in conjunction with either the Inter Fix™ or Inter
antibodies that are capable of crossing the placenta. Reduced ossification
Fix™ RP implants to treat a spinal level.
of the frontal and parietal bones of the skull was noted infrequently (<3%) in
fetuses of rabbit dams immunized to rhBMP-2; however, there was no effect The Infuse™ bone graft/Medtronic interbody fusion device is contraindicated for patients
noted in limb bud development. There are no adequate and well controlled with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2,
studies in human pregnant women. Women of childbearing potential should bovine Type I collagen, or to other components of the formulation and should not be
be warned by their surgeon of potential risk to a fetus and informed of other used in the vicinity of a resected or extant tumor, in patients with any active malignancy, or
possible orthopedic treatments. patients undergoing treatment for a malignancy; in patients who are skeletally immature;
in pregnant women; or in patients with an active infection at the operative site or with an
• Women of childbearing potential should be advised that antibody formation
allergy to titanium, titanium alloy, or polyetheretherketone (PEEK).
to rhBMP-2 or its influence on fetal development has not been completely
assessed. In the clinical trial supporting the safety and effectiveness of the There are no adequate and well-controlled studies in human pregnant women. In an
Infuse™ bone graft/LT-Cage™ lumbar tapered fusion device, 2/277 (0.7%) experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable
patients treated with Infuse™ bone graft component and 1/127 (0.8%) of crossing the placenta. Women of child bearing potential should be warned by their
patients treated with autograft bone developed antibodies to rhBMP-2. The surgeon of potential risk to a fetus and informed of other possible orthopedic treatments.
effect of maternal antibodies to rhBMP-2, as might be present for several The safety and effectiveness of this device has not been established in nursing mothers.
months following device implantation, on the unborn fetus is unknown. Women of child- bearing potential should be advised to not become pregnant for one
Additionally, it is unknown whether fetal expression of BMP-2 could re- year following treatment with this device.
expose mothers who were previously antibody positive. Theoretically, Please see the Infuse™ bone graft package insert for the complete list of indications,
re-exposure may elicit a more powerful immune response to BMP-2 with warnings, precautions, adverse events, clinical results, definition of DDD, and other
possible adverse consequences for the fetus. However, pregnancy did not important medical information. The package insert also matches the sizes of those
lead to an increase in antibodies in the rabbit study. Studies in genetically sized devices that are indicated for use with the appropriate Infuse™ bone graft kit. An
altered mice indicate that BMP-2 is critical to fetal development and that a electronic version of the package insert may be found at [Link]/manuals.
lack of BMP-2 activity may cause neonatal death or birth defects. It is not
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician
known if anti-BMP-2 antibodies may affect fetal development or the extent to
with appropriate training or experience.
which these antibodies may reduce BMP-2 activity.
• Infuse™ bone graft should not be used immediately prior to or during
pregnancy. Women of childbearing potential should be advised not to
become pregnant for one year following treatment with the Infuse™ bone
graft/Medtronic interbody fusion device.
• The safety and effectiveness of the Infuse™ bone graft/Medtronic interbody
fusion device in nursing mothers has not been established. It is not known if
BMP-2 is excreted in human milk.

Brief summary of indications, contraindications,

and warnings for:
Infuse™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device
Infuse™ Bone Graft/Inter Fix™ Threaded Fusion Device
Infuse™ Bone Graft/Inter Fix™ RP Threaded Fusion Device
Infuse™ Bone Graft/Perimeter™ Interbody Fusion Device
Infuse™ Bone Graft/Clydesdale™ Spinal System
Infuse™ Bone Graft/Divergence-L™ Anterior/Oblique Lumbar Fusion System
Infuse™ Bone Graft/Pivox™ Oblique Lateral Spinal System
The Infuse™ bone graft/Medtronic interbody fusion device is indicated for spinal
fusion procedures in skeletally mature patients with degenerative disc disease (DDD)
at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1
retrolisthesis at the involved level.
The following interbody devices and surgical approaches may be used with Infuse™
bone graft:
• The LT-Cage™ lumbar tapered fusion device, implanted via an anterior open or
an anterior laparoscopic approach at a single level.
• The Inter Fix™ or Inter Fix™ RP threaded fusion device, implanted via an
anterior open approach at a single level.
• The Perimeter™ interbody fusion device implanted via a retroperitoneal anterior
lumbar interbody fusion (ALIF) at a single level from L2-S1 or an oblique lateral
interbody fusion (OLIF) approach at a single level from L5-S1.
• The Clydesdale™ spinal system, implanted via an OLIF approach at a single
level from L2-L5.
• The Divergence-L™ anterior/oblique lumbar fusion system interbody device
implanted via an ALIF approach at a single level from L2-S1 or an OLIF approach
at a single level from L5-S1.
• The Pivox™ oblique lateral spinal system implanted via an OLIF approach at a
single-level from L2-L5.
The Infuse™ bone graft/Medtronic interbody fusion device consists of two components
containing three parts – a spinal fusion cage, a recombinant human bone morphogenetic
protein, and a carrier/scaffold for the bone morphogenetic protein and resulting bone.
These components must be used as a system for the prescribed indication described
above. The bone morphogenetic protein solution component must not be used without
the carrier/scaffold component or with a carrier/scaffold component different from the
one described in this document. The Infuse™ bone graft component must not be used
without the Medtronic interbody fusion device component.

35
Medtronic Medtronic Consult instructions for use at this website
Spinal and Biologics Business Sofamor Danek USA, Inc. [Link]/manuals.
Worldwide Headquarters 1800 Pyramid Place
Note: Manuals can be viewed using a current version of any major internet
Memphis, TN 38132
2600 Sofamor Danek Drive browser. For best results, use Adobe Acrobat™* Reader with the browser.
(901) 396-3133
Memphis, TN 38132 (800) 876-3133 Please see the package insert for the complete list of indications,
warnings, precautions, and other important medical information.
Customer Service:
The surgical technique shown is for illustrative purposes only. The
(800) 933-2635
technique(s) actually employed in each case will always depend upon the
[Link] medical judgment of the surgeon exercised before and during surgery as
[Link]/bonegraft to the best mode of treatment for each patient.

VICRYL is a trademark of Ethicon US, LLC, part of the Johnson and Johnson family of companies.
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