O RT H O PA E D I C S

EXACTA
Femoral Stem

SURGICAL TECHNIQUE

0426
TABLE OF CONTENTS

PSystem Overview pag. 1

PIndications, Contraindications & Warnings pag. 2
PPre-Operative planning pag. 3
PSurgical access pag. 4
PFemoral neck osteotomy pag. 4
P Starting The femoral canal pag. 4
PBroaching pag. 5
PFunctinal evaluation pag. 6
PStem implantation pag. 7
PHead implantation pag. 9
PStem removal pag. 10
PPost-Op care pag. 10
PInstruments Set pag. 11

i ATTENTION
This Surgical Technique should be considered a guide or example to
assist orthopaedic Surgeons already trained in Total Hip Arthroplasty.
It's objective is to demonstrate the various instruments used for the
implantation of the EXACTA S stem by permedica. The knowledge
and experience of the Surgeon will guide him throughout the steps of
the implantation.

Both our Sales Representatives and Product Specialists are at Your

complete disposal for any further intormation and/or explanation
about the contents of this Surgical Technique
 EXACTA
FEMORAL STEM SYSTEM
135°

The EXACTA S by permedica is a straight short femoral stem

available in 2 different versions: 127°
EXACTA S cementless monobloc in Standard 135° and
Lateralized 127° version;
EXACTA S PLUS cemented monobloc in Standard 135° and
Lateralized 127° version;
In the versions for cementless application the bone contact
surface presents bioactive coatings to promote optimal
biological integration.
The stem’s design is based upon the principle of a self-locking
stem, thus ensuring optimal anchoring guaranteed by a double
cortical bone contact in the meta-diaphyseal region on the
medial-lateral plane. The reduced length makes the stem
particularly suitable for use with minimally invasive techniques,
including those with direct anterior access.
Longitudinal and transversal grooves on the anterior and
posterior surface guarantees adequate axial and rotational
stability.
The stem has a thin rectangular cross-section thus favouring the
stem’s wedging into the femoral medullary canal. The tapered
diaphyseal portion allows for good centering of the implant in the 135°
femoral canal avoiding high stresses on the distal cortical walls.
The neck section has a reduced diameter enhancing the range of 127°
motion of the joint, avoiding impingement with the inner rim of
the acetabular cup.
A special hole on the top allows the insertion of the stem
introducer, for the correct alignment and positioning of the stem
as well as the coupling with a sliding hammer extraction device.

O RT H O PA E D I C S
Indications & Contraindications
INTENDED USE by Permedica, the surgeon is encouraged to carefully
EXACTA S stems are implantable devices intended to study recommendations, warnings and instructions
be used as femoral components in total or partial hip as well as the specific product information (surgical
replacement procedures, in combination with femoral techniques and technical product description). It is
heads and, eventually, an acetabular component. also advisable to check the website for the
INDICATIONS FOR USE availability of any updates to Instructions for Use.
EXACTA S stems are indicated in case of severe joint Negligence or lack of observance of this aspect
osteo-cartilage degenerations mainly caused by: exonerates the manufacturer from all responsibility
— Advanced stage of joint degeneration resulting from — Products of Permedica may be implanted only by
arthritic, rheumatic, dysplastic or post-traumatic surgeons who are familiar with the general problems
pathologies; of joint replacement, with implant devices, the
— Fractures or avascular necrosis; surgical instruments and who have mastered the
product-specific surgical techniques.
— Negative outcomes of previous interventions such as
joint reconstruction, osteotomy, arthrodesis, total or — Although the implantation of a press-fit femoral
partial arthroplasty; stem has become a routine procedure in the clinical
orthopedics practice, before using the device it is
EXACTA S HaX-Pore, X-Pore and HA stems are indicated necessary to know and get familiar with both the
for primary hip arthroplasties in cases where cortical instruments and the implants. Other than the
bone structure is suitable enough to guarantee a implementation of a correct Surgical Technique, a
correct and enduring mechanical fixation by means good clinical outcome of a THA also depends upon
of press-fit technique; several factors such as bone stock quality, wear
EXACTA S Plus stems are indicated for primary hip values and correct implant sizing.
arthroplasties in cases where cortical bone structure General warnings:
is not suitable to guarantee a correct and enduring — Although the system foresees the use of XL femoral
mechanical fixation by means of press-fit technique heads, this could lead to an alteration of the correct
and, therefore, requiring cementing fixation. biomechanics, with huge lever arms and high
CONTRAINDICATIONS stresses on the implanted components. Therefore,
Absolute contraindications include: use of this type of femoral heads should be carefully
— Systemic infections and any septic condition in the evaluated, also considering the patient's weight and
region surrounding the hip joint; morphology.
— Allergy to implant component materials. — The coupling between stainless steel components
Relative contraindications that could compromise the and those in chromium-cobalt alloy is not permitted
success of the intervention include: as it can cause corrosion according to ISO 21534.
— Chronic or acute local infections, even far from the — Whenever replacement of a ceramic femoral head
implant site (risk of hematogenous spread of the should be necessary, an accurate investigation of the
infection towards the implant site); cone surface should be performed. Any visible
damage (i.e. grooves/scratches) would compromise
— Insufficient bone structures at the proximal or distal
the geometrical/dimensional precision of the cone
level of the joint, which do not guarantee stability to
and use of a new ceramic femoral head must be
the anchoring of the prosthetic components;
avoided.
— Severe vascular, neurological or muscular diseases
Specific warnings:
compromising the involved extremities;
— Size L is the maximum femoral head neck length
— Obesity, overweight;
allowed for EXACTA S and EXACTA S Plus stems in
— Osteoporosis; LATERAL configuration.
— Hypotrophy of the periarticular soft parts; — Size XL is the maximum femoral head neck length
— Dysmetabolic diseases (eg. Kidney failure); allowed for EXACTA S and EXACTA S Plus stems in
— Skeletal immaturity. STANDARD configuration.
WARNINGS / PRECAUTIONS
General precautions:
— Before using a product introduced onto the market

O RT H O PA E D I C S
 1 Pre-operative planning
The aim of preoperative planning is to choose the most suitable
prosthesis to implant, determine the ideal anchorage position,
establish the correct positioning for good biomechanical
reconstruction, correct eventual dysmetria and verify the size. 2
With these objectives in mind it is necessary to carry out a
radiographical exam of the coxo-femoral joint (pelvis and proximal
third of the femur) with projected Anterior-Posterior and Latero-
3
Lateral images, with enough focal distance to obtain an enlargement 1
of at least 15%.
In summary, a correct preoperative planning is advisable in order to Fig. 1: Pre-operative planning
carry out the following general characteristic evaluation:
CENTER OF ROTATION REPRODUCTION
From the A/P pelvis radiograph the controlateral femoral head center
of rotation can be determined, when it is healthy, and the distance
from the radiographic U is quantified.
EVALUATION OF EVENTUAL DYSMETRIA
Three horizontal lines are traced (Fig. 1): a Bi-ischiatic line (1),
between the inferior margins of the ischium; an above acetabular line
(2), between the upper margins of the acetabular cavity, and a bi-
tronchanteric line (3), between the two lesser tronchanters.
If these three lines are parallel amongst themselves, there is no
dysmetria.
If lines (1) and (2) are parallel but line (3) is divergent, there is
dysmetria due to a deformation of the femur.
If lines (2) and (3) are parallel but (1) is divergent, there is a dysmetria
due to a cotyloid deformation.
In the case that all three lines are divergent amongst themselves,
there is a combined dysmetria, determined by a cotyloid deformation
as well as a femur deformation.
EVALUATION OF THE IMPLANT SIZE
After having studied and evaluated the above mentioned Fig. 1b: size evaluation
information via radiographic templates (with 15% magnification),
choose the optimal size combination for the femoral component as EXACTA S
well as the acetabular component (Fig. 1b).
It is possible to prepare a traced radiographic lucent of the hip by 28 mm
heads 32 mm
placing the template over the prosthesis to be implanted. Ø36 mm
i IMPORTANT!
Determine the correct level of the femoral neck osteotomy by placing
the template of the better fitting size over the involved hip x-ray,
aligning the line referring to the center of rotation to the top of the
Greater Trochanter. The Rasp Line marked on the broach will indicate
the correct level of the femoral neck resection.
This mark is engraved on each rasp and indicates the precise sinking
level.
Please note that the length of the neck (Rasp Line-Center of Rotation)
is 41 to 46.5mm depending on the size (refer to table at page 7).
i ATTENTION:
It would be advisable to evaluate, already in the pre-operative
planning phase, the opportunity to use an EXACTA S LATERAL stem.
Failing to execute accurate pre-operative planning could lead to poor
results. The intervention should be carefully planned based upon X-
Ray screening.
Before the operation it is furthermore necessary to investigate the
possibility of any possible allergic reactions of the patient towards
implantable device materials.
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O RT H O PA E D I C S
 2 SURGICAL ACCESS
Access to the hip joint can be achieved by following any standard
surgical approach, according to Surgeon’s preferences and/or
habits, providing that an adequate exposure is ensured.
For best surgical results it is always advisable use of the most
familiar surgical approach.

3 FEMORAL NECK OSTEOTOMY

Before proceeding to the osteotomy of the femoral head, it is
important to remove any osteophytes and periosteal tissues to
allow clear vision of the head/neck limits.
The neck osteotomy is carried out using an oscillating saw,
referring to the lesser trochanter and at the distance measured in
the pre-operative planning (Fig. 2). LESSER
The femoral head is removed and preserved to be utilized for TROCHANTER
eventual bone grafts.

Fig. 2:

4 STARTING THE FEMORAL CANAL

The medullary canal is initiated utilizing the Moore Starting Chisel
(S12022) assembled to the Rasp Handle. Striking the chisel, a
rectangular cleft is made allowing for the insertion of the first
rasp. The chisel must be held as laterally as possible (Fig. 3).

S12022

Identify the axis of the femoral canal using a long curette or the
Diaphyseal Starting Awl (S10006).
A Curved Starting Rasp (S13281) is also available in the
Instruments Set. Fig. 3:

S10006

S13281

O RT H O PA E D I C S
 5 BROACHING
A
OPEN

To lock/unlock the broach onto the Handle (Fig. 4): LOCK

j open the locking system by pulling the lever A

k engage the broach in the connection B
l lock the broach by pushing back the lever A

B
Fig. 4: broach connection .

NOTE:
In addition to the CURVED Rasp Handle (S11600) supplied as
standard, it is also available a STRAIGHT Handle and Double Off-
set Handles in LEFT and RIGHT version (for MIS/Anterior
Approach).
A special Adapter (S11607) is also available to allow broaches
impaction by using the Sliding Hammer Impactor (S10012) as
well as a pneumatic hammer (Woodpecker).

S11644 Mark S Rasp Handle - Double Off-set LEFT

a

S11601 Mark S Rasp Handle - Straight

b

S11643 Mark S Rasp Handle - Double Off-set RIGHT

The smallest size broach is assembled onto the Rasp Handle and
inserted into the prepared site. The special design of both the
Fig. 5: correct insertion
broach and the handle make it possible to preserve the Greater
of the broach
Trochanter, allowing to insert the broach slightly medially (Fig.
5a) and then change the direction to follow the diaphyseal axis by
pushing the handle laterally (towards the Greater Trochanter)
while hammering the broach.
The broach must be pushed until totally embedded. It may be
necessary to repeat the extraction and reinsertion a few times to
help removal of bony debrise.

O RT H O PA E D I C S
Proceed inserting the next broaches, increasing the size until
reaching the correct size determined in the pre-op planning
(anyway the surgeon should feel the broach locking onto the
cortical walls and not sinking any further, stable to torsion and
opposing resistance to extraction). If the osteotomy has been
made in compliance to the pre-op planning, the Rasp Line mark
should be leveled to the osteotomy (Fig. 6). If the broach sinks
further, the next size is normally required.
Whenever the final broach should be considerably smaller (two
or more sizes) than that evaluated during the pre-operative
planning it would be necessary to verify the correct insertion of
the rasp within the femoral canal and, if necessary, carry out any
corrections before inserting the final implant.

6 FUNCTIONAL EVALUATION Fig. 6: correct sinking

of the final broach
Having reached the desired fit, the last broach utilized is left in
place. Inserting onto it the proper Trial Neck and a Trial Head, it
will be possible to carry out a trial reduction.

i ATTENTION:
The Trial Necks are available for STANDARD
(S11624) and LATERAL (S11625) version,
both fitting all sizes of rasps.

STANDARD

LATERALIZED

L
M
S

The Lateralized option allows to change the angle of the neck

(127°), increasing the offset and improving muscles tension
without changing the limb length.

O RT H O PA E D I C S
After inserting a Trial Head compatible with the inner diameter
of the implanted acetabular cup’s liner (Fig. 7), reduce the hip to
evaluate mobility and stability through a full range of motion
(high flexion, external/internal rotation, abduction/adduction)
and check for any impingement.
The appropriate neck length of the Femoral Head to be used is
determined as well. This is considered optimal if, by extending
the limb and applying traction, an excursion of about 10mm is
allowed. If the excursion should be different, evaluate the
opportunity of using a Short or Long neck Femoral Head.
The neck length of the Trial Heads is identifiable by a colour
coding:
GREEN = SHORT Neck / XL-Neck (old type)
BLUE = MEDIUM Neck
Fig. 7
GREY = LONG Neck
YELLOW = XL (Extra-Long) Neck

WARNINGS:
R the use of Extralong femoral heads, although foreseen by the
system, could lead to an alteration of the correct biomechanics
with huge lever arms and high stresses on the implanted
components. Therefore, use of this type of femoral heads
should be carefully evaluated, also considering the patient’s
weight and morphology.
R DO NOT USE XL (ExtraLong) femoral heads with EXACTA S
LATERAL stems.

7 IMPLANTATION of the DEFINITIVE STEM

PRESSFIT STEM
The definitive Stem to be implanted will be the same size of the
last broach utilized.
Once drawn from the sterile packaging, the Stem is manually
engaged into the previously prepaired femoral site.
Screw the apposite Stem Impacting End (S19503) onto the
Universal Handle - Quick Fix (S53099).

S53099

S19503
Fig. 9

Lodge the tip into the niche onto extreme

top of the stem(Fig. 8) and impact with a
hammer until complete seating (Fig. 9).

Fig. 8

O RT H O PA E D I C S
CEMENTED STEM
The definitive Stem to be implanted will be the same size of the
last rasp utilized.
i INFORMATION: the cemented stem is undersized compared
to the rasp to allow 1mm cement mantle around the prosthesis: if
a thicker cement mantle should be desired, a smaller size can be
Fig. 10
selected having care to adjust its insertion accordingly with the
sinking lines.
Once drawn from the sterile packag, the Stem is engaged onto
the Stem Extraction Threaded End S13284 (which can be used
also as an introducer) connected with the Universal Handle -
Quick Fix (S53099) and screwed into the threaded hole on the top
of the stem (Fig. 10).

S53099

S13284

The prepared femoral cavity is filled with bone cement, following

the most favourite cementing technique. It is anyway advisable
to plug the diaphysis distally to the stem in order to avoid cement
leakage towards the distal femur.
The stem is driven into the femoral canal and sunk till it’s final
seating. For a correct sinking refer to the sinking lines marked on
the proximal part of the stem.
Apply a continuous pressure till complete hardening of the bone
cement, removing the bone cement in excess overflowing from Fig. 11a: sinking level
the femoral canal. referring to the
Greater Trochanter

i ATTENTION: the central sinking line refers to the resection

line marked on the rasp (Fig.11b). Please remind anyway that a
reliable landmark to refer to is the center of the morse taper
(center of rotation) aligned to the Greater Trochanter (Fig. 11a).

Fig. 11b: sinking lines.

O RT H O PA E D I C S
 8 FEMORAL HEAD IMPLANTATION
Once the stem is definitively seated it will be possible to repeat a
trial, in case of any doubt,by using the Trial Heads. Once the
correct Femoral Head has been defined, proceed with the
implantation of the definitive one.
Remove the plastic cap protecting the taper and manually insert
the selected Femoral Head onto the stem taper, applying axial
pressure and torsion to achieve perfect locking. Fig. 12
After positioning, the Femoral Head is impacted (Fig. 12) using
the appropriate Impacting End (S19502) assembled on the
Universal Handle -Quick Fix (S53099).

S19502 S53099

WARNINGS:
þ Before inserting the Femoral Head make sure that the cone
surface is perfectly clean and dry.
þ Ceramic Femoral Heads must NEVER be directly impacted
with metal instruments.
þ Whenever replacement of a ceramic Femoral Head should be
necessary, an accurate investigation of the cone surface
s h o u l d b e e f fe c t e d . A ny v i s i b l e d a m a g e ( i . e .
grooves/scratches) would compromise the
geometrical/dimensional precision of the cone and use of a
new ceramic Femoral Head must be AVOIDED.

Then proceed with final reduction of the joint and wound

closure.

O RT H O PA E D I C S
 9 STEM REMOVAL
Whenever it should be necessary to remove the implanted stem,
the instruments set provides an apposite Extraction Threaded
End (S13284) to be connected with the Universal Handle - Quick
Fix (S19501) and screwed into the threaded hole on the top of the
stem (Fig. 13).
S13284

Fig. 13
S53099

Alternatively an Extraction Threaded Adapter to be used with the

Sliding Hammer is also available upon request.
In this case, connect the quick coupling Extraction Adapter
(S11012) to the Sliding Hammer Impactor/Extractor (S10012)
and screw it into the threaded hole in the top of the stem (Fig.
13).
S11012

S10012

10 POST-OPERATIVE CARE
Post-op care strategy is very important to allow the patient a
correct recovery. The guidelines are established by the Surgeon
and should consider several factors such as age, weight and bony
structure of the patient.
In any case, it is necessary to avoid excessive load of the lower
limb for a certain amount of time.
i ATTENTION: the Surgeon is required to schedule regular
check ups to veryfy the implant status.

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O RT H O PA E D I C S
 S11660 EXACTA S Stems Instruments Set

S10090 FEMORAL STEMS

BASIC INSTRUMENTS
Generic instruments common to all the stems

S10072 FEMORAL STEMS Universal Instruments Tray - V2 INOX supp.

1 S10006 Diaphyseal Starting Awl - STRAIGHT
2 S11600 RASP HANDLE Mark S - CURVED
3 S11601 RASP HANDLE Mark S - STRAIGHT
4 S12022 MOORE STARTING CHISEL - Mark S
5 S13281 MOUSE TAIL STARTING RASP
6 S13284 STEM EXTRACTION THREADED END - Quick Fix
7 S19502 HEAD IMPACTING END - Quick Fix
8 S19503 STEM IMPACTING END - Buttonholed - Quick Fix
9 S19504 CONICAL IMPACTING TIP - Quick Fix
10 S30079 TOMMY BAR
A S20131 TRIAL HEAD Ø 32mm - SHORT NECK
B S20132 TRIAL HEAD Ø 32mm - MEDIUM NECK
11
C S20133 TRIAL HEAD Ø 32mm - LONG NECK
D S20134 TRIAL HEAD Ø 32mm - XL NECK
A S20137 TRIAL HEAD Ø 36mm - SHORT NECK
B
12 S20138 TRIAL HEAD Ø 36mm - MEDIUM NECK
C S20139 TRIAL HEAD Ø 36mm - LONG NECK
D S20140 TRIAL HEAD Ø 36mm - XL NECK
A S20181 TRIAL HEAD Ø 28mm - SHORT NECK
13 B S20182 TRIAL HEAD Ø 28mm - MEDIUM NECK
C S20183 TRIAL HEAD Ø 28mm - LONG NECK
D S20184 TRIAL HEAD Ø 28mm - XL NECK
14 S53099 UNIVERSAL HANDLE with Lock - Quick Fix

OPTIONAL INSTRUMENTS
S20145 TRIAL HEAD Ø 40mm - SHORT NECK
S20146 TRIAL HEAD Ø 40mm - MEDIUM NECK
S20147 TRIAL HEAD Ø 40mm - LONG NECK
S20148 TRIAL HEAD Ø 40mm - XL NECK

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O RT H O PA E D I C S
 S11660 EXACTA S Stems Instruments Set

S11945 EXACTA S STEM RASPS SET

S11658 EXACTA S: Rasps Tray 25x28cm - V2 INOX supp.

1 S11624 TRIAL NECK for Exacta S Rasp - Mark S - Standard
2 S11625 TRIAL NECK for Exacta S Rasp - Mark S - Lateralized
3 S11751 EXACTA S: Mark S Rasp - LONG Pitch- size 1
4 S11752 EXACTA S: Mark S Rasp - LONG Pitch- size 2
5 S11753 EXACTA S: Mark S Rasp - LONG Pitch- size 3
6 S11754 EXACTA S: Mark S Rasp - LONG Pitch- size 4
7 S11755 EXACTA S: Mark S Rasp - LONG Pitch- size 5
8 S11756 EXACTA S: Mark S Rasp - LONG Pitch- size 6
9 S11757 EXACTA S: Mark S Rasp - LONG Pitch- size 7
10 S11758 EXACTA S: Mark S Rasp - LONG Pitch- size 8
11 S11759 EXACTA S: Mark S Rasp - LONG Pitch- size 9
12 S11760 EXACTA S: Mark S Rasp - LONG Pitch- size 10

OPTIONAL INSTRUMENTS
13 S11761 EXACTA S: Mark S Rasp - LONG Pitch- size 11
14 S11762 EXACTA S: Mark S Rasp - LONG Pitch- size 12

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O RT H O PA E D I C S
Order information
* References with asterisk are available ON REQUEST

EXACTA S Femoral Stem - Cementless

Standard - CCD 135° Lateral - CCD 127°

HaX-Pore X-Pore HA HaX-Pore X-Pore HA
Offset
Size L Offset L2 Offset L2
mm mm mm REF. REF. REF. mm mm REF. REF. REF.
1 91,0 38,6 39,0 11961 11861* 11641* 44,9 44,3 11971 11881* 11661*
L2 2 98,2 39,3 39,0 11962 11862* 11642* 45,5 44,3 11972 11882* 11662*
CCD 3 101,6 40,0 41,0 11963 11863* 11643* 46,3 46,3 11973 11883* 11663*
4 105,3 40,8 41,0 11964 11864* 11644* 47,0 46,3 11974 11884* 11664*
5 108,8 41,5 42,0 11965 11865* 11645* 47,7 47,3 11975 11885* 11665*
6 112,4 42,2 42,0 11966 11866* 11646* 48,4 47,3 11976 11586* 11666*
L 7 115,9 42,9 43,0 11967 11867* 11647* 49,1 48,3 11977 11887* 11667*
8 119,3 43,6 43,0 11968 11868* 11648* 49,1 48,3 11978 11888* 11668*
9 122,8 43,6 44,0 11979 11869* 11649* 49,8 49,3 11989 11889* 11669*
10 125,8 44,1 44,0 11980 11870* 11650* 50,3 49,3 11990 11890* 11670*
11 129,8 45,6 45,0 11981* 11871* 11651* 51,8 50,3 11991* 11891* 11671*
12 133,3 45,6 45,0 11982* 11872* 11652* 51,8 50,3 11992* 11892* 11672*

EXACTA S PLUS Femoral Stem - Cemented

Standard - CCD 135° Lateral - CCD 127°

Offset
Size L Offset L2 Offset L2
mm mm mm REF. mm mm REF.
1 90,0 38,6 39,0 12011 44,9 44,3 12031
2 91,3 39,3 39,0 12012 45,5 44,3 12032
L2 3 98,3 40,0 41,0 12013 46,3 46,3 12033
CCD 4 101,8 40,8 41,0 12014 47,0 46,3 12034
5 105,4 41,5 42,0 12015 47,7 47,3 12035
6 108,9 42,2 42,0 12016 48,4 47,3 12036
7 112,3 42,9 43,0 12017 49,1 48,3 12037
L 8 115,8 43,6 43,0 12018 49,1 48,3 12038
9 119,3 43,6 44,0 12019 49,8 49,3 12039
10 122,8 44,1 44,0 12020 50,3 49,3 12040
11 126,3 45,6 45,0 12021* 51,8 50,3 12041*
12 129,8 45,6 45,0 12022* 51,8 50,3 12042*

Product Information
MATERIALS:
Cementless stems: Titanium Aluminium Niobium forged alloy (Ti6Al7Nb) ISO5832/11
Cemented stem: PM734 higly nitrogenized Stainless Steel forged alloy ISO5832/9
SURFACE FINISHING:
EXACTA S HaX-Pore®: double coating 300µm pure Titanium+50µm Hydroxyapatite Ca10(PO4)6(OH)2 plasma sprayed
EXACTA S X-Pore: coating 300µm pure Titanium plasma sprayed
EXACTA S HA: coating 80µm Hydroxyapatite Ca10(PO4)6(OH)2 plasma sprayed
EXACTA S Plus: mirror polished finishing surface
STERILIZATION:
Method: Irradiation (R- nominal dose 25 kGy) or Vaporized Hydrogen Peroxide (VH2O2).
Validity: 10 years .
CLASSIFICATION:
Class III as reported in Directive 2005/50/CE (and related D.lgs 26 april 2007 n.65) concerning re-classification of Hip, Knee and
Shoulder joint prostheses which modifies classification criteria13 of Annex IX of Directive 93/42/CEE and next integrations and
amendements.
 O RT H O PA E D I C S

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