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ANATOMIC ® Primary Total Knee System Fixed bearing Cemented or cementless Surgical Technique i.M.A.G.E. ® Patient Specific Instrumentation 4-in-1

Surgical Technique i.M.A.G.E. Patient Specific ...® Patient Specific Instrumentation 4-in-1. 2 3 ... • Patient-specific instrumentation is designed according to the ... osteotomy

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Page 1: Surgical Technique i.M.A.G.E. Patient Specific ...® Patient Specific Instrumentation 4-in-1. 2 3 ... • Patient-specific instrumentation is designed according to the ... osteotomy

ANATOMIC®

Primary Total Knee SystemFixed bearingCemented or cementless

Surgical Techniquei.M.A.G.E.® PatientSpecific Instrumentation4-in-1

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2 3

ANATOMIC® Total Knee SystemOverview

�The�ANATOMIC®�TKS�is�a�PCL-sacrificing,�posterior-stabilized,�fixed�bearing�implant�for�primary�knee�arthroplasty.�Its�mediolateral�coverage�matches�the�morphology�of�the�femur.�Stability�is�provided:�� -�in�extension�thanks�to�a�congruent�anterior�rim�� -��in�flexion�thanks�to�a�late�contact�between�the�cam�and�the�spine�of�the�posterior-

stabilization�mechanism.

6°�anterior�cut

Made�of�cobalt-chrome;�cementless�version�has�dual�coating�of�plasma-sprayed�titanium�and�HA�(80�μm�each);�cemented�version�is�microblasted�

Two�stabilisation�pegs��8�mm,�length�13�mm Thickness:�8�mm

Consistent�radius�of�curvature�from�0°�to�more�than�100°�flexion

Post-cam�contact�beyond�90°�flexion�and�up�to�130°�flexion

2°�posterior�cut

Reduced�radius�of��curvature�to�increase��flexion

Trochlear�groove�lateralised�by�an�average�of�2.3�mm

Asymmetrical�contact�surfaces:�ü�quasi-physiological�joint�kinematics

1. Femoral component:

ANATOMIC® Total Knee SystemOverview

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4 5

Polyethylene�patellar�implant�available�in�two�versions:�

2. Tibial component:

Fixed-bearing insert:

Thickness:�8�mm

Polyethylene��component�

Anterior�chamfer

Lateral��chamfers

The�shape�of�the�post’s�backside�allows�rollback

Thickest�in�posterior�aspect√�Creep�in�flexion�minimised

Flat�baseplate�posteriorly√�Condyle�rollback�during�flexion

Anterior�congruency√�Extension�stability�√��Allows�up�to�10°�

recurvatum�(before�post-cam�contact)

Posterior�post�position�√�beneficial�for�flexion

Clips�into�anterior�part�of�baseplate

Thickness:�7�mm

Distance�between�pegs�changes�based�on�size

Onset patellar implant - cemented Inset patellar implant - cemented6�posterior�tabs�hook��onto�insert

3�sizes�of�delta�wings��(sizes�0-1-2,�3-4-5,�6-7-8)

Compatible�long�stem:� -��10�to�16�mm� -�Lengths�75�to�200�mm

Cylinder-shaped�tibial�keel�is�the�same�for�all�sizes�15�mm,�length�35�mm

Made�of�cobalt-chrome;�cementless�version�has�dual�coating�of�plasma-sprayed�titanium�and�HA�(80�μm�each);�cemented�version�is�microblasted

Mirror-polished�contact�surface�with�fixed�insert

Extraction�hole Area�for�connecting�the�insert

Posterior�anatomical�shape�cut-out

ANATOMIC® Total Knee SystemOverview

ANATOMIC® Total Knee SystemOverview

Tibial baseplate:

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6 7

T0 T1

T2 T3

T4 T5

T6

T7

T8

50

55

60

65

70

75

80

45 50 55 60 65 70

ΔAP : 2,6 mm

ΔML : 2 mm

ΔML : 3,2 mm

AP

ML

3. Product range:

•�• Femoral components:� -�Cemented:�9�sizes�(0�and�8�are�optional)�� -�Cementless:�9�sizes�(0�and�8�are�optional)�Mediolateral�implant�coverage�matches�bone�morphology:

4. Components compatibility:

•�• Patellar components:� -�Onset�patellar�implant�–�cemented:�Ø�30,�33�and�36�mm� -�Inset�patellar�implant�–�cemented:�Ø�23,�26�and�29�mm

•�• Tibial components:� -�Cemented:�9�sizes�(0�and�8�are�optional)�� -�Cementless:�9�sizes�(0�and�8�are�optional)

� -�Inserts:��9�sizes�(0�and�8�are�optional)�6�heights�(10,�12,�14,�16,�18�and�20�mm)

�ML�width�as�a�function�of�AP�size

Difference between sizes: 2.3 mm

Difference between sizes: 3.5 mm

ANATOMIC® Total Knee SystemOverview

T0 T1

T2 T3

T4 T5

T6

T7

T8

50

55

60

65

70

75

80

45 50 55 60 65 70

ΔAP : 2,6 mm

ΔML : 2 mm

ΔML : 3,2 mm

AP

AP

ML

ML

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8 9

+1,5°

+3°

+4,5°

The i.M.A.G.E.® Process

1•�Online�ordering

•�Images�sending

2•�Segmentation

•�Construction�of�mechanical�axis

•�5�steps:

3

•�Three-dimensional�planning

4

•�Design�of�Pin�Positioning�Guides

•�Manufactured�by�selective�laser�sintering

5

•��Instrumentation�delivered�to�hospital

•��Decontamination�and�sterilization�by�hospital

i.M.A.G.E.® patient-specific instrumentationOverview

•�i.M.A.G.E.®�Patient-specific�instrumentation�is: - For single use. - Manufactured based on the patient’s CT or MRI images. - Used to position the Pins on which the Distal Femoral, 4-in-1 Femoral, and Tibial Resection

Guides will be placed.

•�It�allows�intraoperative�check�of: - contact areas comparing with Phantoms - femoral rotation - anterior femoral cut - tibial mechanical axis

Tibial�Pin�Positioning�GuideMaterial:�polyamide

Removable�Tibial��Pin�Guide

Hole�to�check�tibial�mechanical�axis

Tibia�Phantom

Removable�4-in-1�Distal�Femoral�Pin�Guide

Femoral�Pin�Positioning�GuideMaterial:�polyamide

Slot�used�to�check�anterior�resection

Removable�4-in-1�Femoral�Pin�Guideü��Femoral�rotation�can�be�

adjusted�intraoperativelyHole�used�to�check�femoral�rotation

Femur��Phantom

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7

11 12

82

3 4

1

5 6

9 10

Summary of surgical technique

Positioning�of�4-in-1�Resection�Guide Femoral�cutsInsertion�of�tibial�Pins

Positioning�of�Femoral�Pin�Positioning�GuideTibial�cut

Positioning�of�Tibial�Pin�Positioning�Guide

Insertion�of�femoral�Pins Distal�femoral�cut

•��Set�the�Removable�Tibial�Pin.�Guide�on�the�Tibial�Pin�Positioning�Guide.

•��Place�these�components�on�the�proximal�tibia.

•��Make�sure�the�Tibial�Pin�Positioning�Guide�is�stable�(unique position).

•��Put�the�Headless�Pins�back�in�the�distal�holes.

•��Place�the�4-in-1�Femoral�Resection�Guide�corresponding�to�the�planned�size�on�the�distal�Pins�in�the�middle�holes�(neutral�position)

•��Use�the�Resection�Gauge�to�ensure�the�anterior�resection�will�respect�the�anterior�cortex.

•��Insert�two�Headless�Pins�into�the�4-in-1�Distal�Femoral�Pin�Guide�using�the�Motorised�Hand-piece�(with�the�Universal�or�AO�Connector)�and�two�other�Pins�in�the�4-in-1�Femoral�Pin�Guide�+0°�Rotation,�while�holding�the�Pin�Positioning�Guide�firmly�in�place.

•��Check�the�anterior�cut�and�the�planned�external�rotation.

•��Remove�the�4-in-1�Femoral�Pin�Guide�and�the�distal�Pins.

•��Remove�the�4-in-1�Distal�Femoral�Pin�Guide,�and�then�the�Femoral�Pin�Positioning�Guide.

•��Place�the�Tibial�Resection�Guide�on�the�Pins�in�the�0�mm�position.

•��Use�3�converging�Headed�Pins�to�stabilise�the�Resection�Guide.

•��Make�the�tibial�cut.

•��The�+2�and�+4�positions�will�be�used�if�the�tibia�needs�to�be�recut.

•��Insert�two�Pins�into�the�Tibial�Pin�Guide�using�the�Motorised�Hand-piece,�while�holding�the�Pin�Positioning�Guide�firmly�in�place.

•��Check�the�tibial�mechanical�axis.

•��Remove�the�Tibial�Pin�Guide�and�then�the�Tibial�Pin�Positioning�Guide.

•��Secure�the�Resection�Guide�with�2�lateral�Pins.

•��Make�the�anterior�and�posterior�cuts�.

•��Remove�the�distal�Pins�using�the�Pin�Extractor.

•��Make�the�two�chamfer�cuts.

•��Place�the�Distal�Femoral�Resection�Guide�on�the�Headless�Pins�in�the�0�mm�position,�flush�against�the�femoral�trochlea.

•��Check�the�cut�thickness�with�the�Resection�Gauge.

•��Use�two�other�converging�Pins�to�stabilise�the�Resection�Guide.

•��Perform�the�distal�cut.

•��Set�the�Removable�4-in-1�distal�Femoral�Pin�Guide�and�Removable�4-in-1�Femoral�Pin�Guide�+0°�Rotation�on�the�Femoral�Pin�Positioning�Guide.

•��Place�these�components�on�the�anterior�and�distal�femur.

•��Make�sure�the�Femoral�Pin�Positioning�Guide�is�stable�(unique position).

Note:�After�determining�the�flexion�gaps,�additional�external�rotation�of�1.5°,�3°�or�4.5°�can�be�added�to�the�planned�rotation�with�the�Removable�Femoral�Pin�Guides.

Summary of surgical technique

Tibial�preparationFemoral�preparations•��Choose�and�place�the�femoral�

preparation�guide�of�the�same�size�as�the�4-in-1�resection�guide�used.

•��Prepare:-��The�femoral�notch�with�the�

notch�reamer-��The�trochlea�with�the�

trochlear�box�chisel-��PS�cam�space�with�the�

L-shaped�chisel

•��Finalise�the�preparation�by�removing�the�bone�ridge�with�the�osteotome.

•��The�peg�holes�preparation�can�be�prepared�either�using�the�femoral�preparation�guide�or�using�the�trial�component.

•��Determine�the�size�of�the�tibial�baseplate�needed.�The�baseplate�can�be�one�size�larger�or�smaller�than�the�size�of�the�femoral�component.�

Important: Remove the 2 headless pins left in the tibia.

•��Place�the�tibial�fin�punch�guide�onto�the�trial�baseplate�and�verify�that�the�sizes�are�compatible.

•��With�a�motorized�handpiece,�drive�the�tibial�keel�drill�bit�into�the�guide�until�it�stops.

•��Prepare�the�fins�by�pushing�the�appropriately�sized�tibial�fin�punch�until�it�stops.

•��Position�the�patella�guide�with�the�lugs�facing�the�anterior�side�of�the�patella.

•��Using�the�adjustment�wheel,�slide�the�8�mm�sensor�into�the�slot�such�that�it�touches�the�joint�face.�The�jaws�of�the�forceps�must�be�opened.

•��Tighten�and�lock�the�forceps.

•��Perform�the�resection�through�the�slot.

Patella�preparationResurfacing�option

Patellar�preparationPatellar�reaming�option

•��Assemble�the�clamp�corresponding�to�the�chosen�patellar�implant�size�onto�the�locking�patellar�reaming�forceps.

•��The�inferior�jaw�on�the�reaming�forceps�must�rest�against�the�anterior�side�of�the�patella.�Use�the�thumb�knob�to�tighten�the�reaming�forceps.

•��Ream�the�patella�until�the�stop�is�reached.��

•��Remove�the�patellar�reaming�forceps,�place�the�trial�cemented�patellar�implant�and�test�the�articulation�of�the�patella�in�the�trochlea.

•��Assemble�the�patella�binding�clamp�onto�the�locking�patellar�reaming�forceps.

•��Insert�the�chosen�patellar�component.

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Preoperative planning based on CT scan

Preoperative planning based on MRI

Preoperative planning

•��Patient-specific�instrumentation�is�designed�according�to�the�preoperative�planning�in�order�to�insert�the�Pins�for�the�Tibial,�Distal�Femoral�and�4-in-1�Femoral�Resection�Guides.�Preoperative�planning�is�performed�using�the�i.M.A.G.E.®�Planning�Software.

•��The�i.M.A.G.E.®�Planning�Software�is�used�to�determine�the�size�and�the�position�of�the�ANATOMIC®�total�knee�implants�before�the�procedure.

•�The�following�parameters�can�be�adjusted�in�the�software:

-�On�the�femur:- Femoral component size- Anterior/posterior position- Flexum/recurvatum- Internal/external rotation- Height of distal cut- Medial/lateral positioning- Varus/valgus positioning

-�On�the�tibia:- Anterior/posterior slope- Height of tibial cut- Anterior/posterior position- Medial/lateral positioning- Varus/valgus positioning- Internal/external rotation

-��Estimated�cartilage�height�for�the�tibial�and�distal�femoral�resection�height�reference�(only�for�planning�based�on�CT�images).

•��Changing�these�parameters�will�update�in�real-time�the�three-dimensional�bone�model�generated�based�on�the�patient’s�CT�or�MRI�images.

•��The�Planning�Software,�instructions�for�its�use�and�the�imaging�protocols�can�be�downloaded�from�https://image.amplitude-ortho.com.�Please�contact�your�Amplitude�sales�rep�for�access.

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Recommendations

•��We�do�not�recommend�using�the�system�in�patients�who�have�an�existing�implant�near�the�device’s�application�site.�Examples:�osteotomy�plate,�nail,�staple,�screw,�etc.�These�could�induce�artefacts�that�could�alter�the�quality�of�the�CT�or�MRI�images.

•��Before�starting�the�procedure,�make�sure�the�patient-specific�data�on�each�Pin�Positioning�Guide�and�Phantom�are�correct.�Do�not�use�these�items�if�the�patient�identification�is�not�clearly�visible.

Example of patient identification: 0000001-F-SUR-X-PN- 0000001: 7-digit number- F: first letter of patient’s first name- SUR: first 3 letters of patient’s surname- X: operated side, left (L) or right (R)- PN: surgeon’s initials

•� Do not resect any of the osteophytes�because�they�are�needed�to�position�the�Pin�Positioning�Guides.

•��If�an�osteophyte�that�is�not�under�a�contact�area�interferes�with�exact�positioning�of�the�Pin�Positioning�Guide,�remove�this�osteophyte�and�try�again�to�set�the�Pin�Positioning�Guide�in�place.

•�The�surgeon�can�start�with�either�the�tibial�cut�or�the�distal�femoral�cut.

REMINDER: The purpose of this surgical technique description is to provide instructions on how to use the instrumentation properly. The surgeon is fully responsible for choosing and performing the approach and surgical technique.

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Insertion of tibial Pins

•��Insert�two�Pins�into�the�Tibial�Pin�Guide�using�the�Motorised�Hand-piece�(with�the�Universal�or�AO�Connector),�while�holding�the�Pin�Positioning�Guide�firmly�in�place�(if�needed,�the�pin�holes�can�be�pre-drilled�with�an�Ø3.2�mm�Drill�Bit.

NOTE: Insert the medial Pin first to prevent the Tibial Pin Positioning Guide from tipping.

•��Check�the�tibial�mechanical�axis�(varus/valgus�and�slope)�by�inserting�the�Extramedullary�Alignment�Rod�in�the�hole�on�the�Tibial�Pin�Positioning�Guide.

•��Remove�the�Tibial�Pin�Guide�and�then�the�Tibial�Pin�Positioning�Guide�(make�sure�the�Pins�are�stable).

Positioning of Tibial Pin Positioning Guide

•�Set�the�Removable�Tibial�Pin�Guide�on�the�Tibial�Pin�Positioning�Guide.

•��Carry�out�the�following�steps�before�placing�these�components�on�the�proximal�tibia:- Flex the knee.- Perform medial and lateral meniscectomy.- Use the Tibia Phantom to locate the contact areas on the tibia.- Make sure there is no fibrous tissue on the tibial contact areas that will be used to position

the Pin Positioning Guide.

•��Make�sure�the�Tibial�Pin�Positioning�Guide�is�stable�(unique position)�and�rests�against�the�anterior�tibia.

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Flexion and extension gaps

•��It�is�then�possible�to�check�gaps�using�a�10�mm�Spacer�mounted�on�the�Universal�Handle�which�may�accomodate�Extramedullary�Alignment�Rods.

•�2�mm�and�4�mm�Spacers�may�also�added�to�the�10�mm�Spacer�to�improve�ligament�tension.

Tibial cut

•��Place�the�Tibial�Resection�Guide�(right�or�left)�on�the�Pins�in�the�0�mm�position�and�make�sure�it�is�flush�with�the�anterior�tibial�cortex.

NOTE: At this point, two checks can be performed:- The resection height can be checked using the Tibial Stylus or the Resection Gauge.

This check is recommended in the context of CT planning because the cartilage thickness used as the resection height reference is an estimate.

- The tibial mechanical axis can be checked with the Alignment Gauge and Extramedullary Alignment Rod.

•�Use�three�converging�Headed�Pins�to�stabilise�the�Resection�Guide.

•�Make�the�tibial�cut.

•�Remove�the�Headed�Pins�with�the�Pin�Extractor.

•��Slide�the�Resection�Guide�off�the�Pins,�by�leaving�the�Pins�in�place�in�case�a�recut�is�necessary�(the�+2�and�+4�holes�will�be�used�at�that�time)..

NOTE: Depending on the bone quality, a 145 mm long, Ø 3,2 mm Drill Bit can be used to make pilot holes for the Pins.

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Insertion of femoral Pins

•��Insert�two�Headless�Pins�into�the�4-in-1�Distal�Femoral�Pin�Guide�using�the�Motorised�Hand-piece�(with�the�Universal�or�AO�Connector),�while�holding�the�Pin�Positioning�Guide�firmly�in�place�(if�needed,�the�pin�holes�can�be�pre-drilled�with�an�Ø3.2�mm�Drill�Bit).

NOTE: The Universal Connector can be assembled with the Universal T-handle.

•��If�the�four�other�resections�will�be�made�using�the�i.M.A.G.E.®�System,�insert�two�Headless�Pins�distally,�while�holding�the�Pin�Positioning�Guide�firmly�in�place�and�making�sure�it�is�stable

•��Check�the�anterior�rescetion�using�the�Resection�Gauge�and�check�the�external�rotation�using�the�Blunt�K-wire.

•�Remove�the�4-in-1�Femoral�Pin�Guide�and�the�distal�Pins.

•�Remove�the�4-in-1�Distal�Femoral�Pin�Guide,�and�then�the�Femoral�Pin�Positioning�Guide..

NOTE: If the 4-in-1 Femoral Resection Guide is positioned using the i.M.A.G.E.® System, we recommend marking the distal holes made by the Headless Pins with methylene blue to make them easier to find later on.

Positioning of Femoral Pin Positioning Guide

•��Place�the�Removable�4-in-1�Distal�Femoral�Pin�Guide�in�the�anterior�holes�of�the�Femoral�Pin�Positioning�Guide.

•��Place�the�Removable�4-in-1�Femoral�Pin�Guide�+0°�Rotation�in�the�distal�holes�of�the�Femoral�Pin�Positioning�Guide.

•�Carry�out�the�following�steps�before�placing�these�components�on�the�anterior�and�distal�femur:

- Flex the knee 90°.- Use the Femur Phantom to locate the contact areas on the femur.- Make sure there is no fibrous tissue on the femoral contact areas that will be used to position

the Pin Positioning Guide.- Expose the femur in the frontal plane using Hohmann Retractors.

•��Make�sure�the�Femoral�Pin�Positioning�Guide�is�stable�(unique position)�and�rests�against�bone�in�the�anteromedial�and�anterolateral�aspects�(cartilage/bone�boundary)�and�in�the�mediolateral�aspect�(cartilage/bone�boundary).

NOTE: After determining the flexion gaps, an additional external rotation of 1.5°, 3° or 4.5° can be added to the planned rotation. To do this, remove the 4-in-1 Femoral Pin Guide +0° Rotation and replace it with the 4-in-1 Femoral Pin Guide +1.5°, +3° or +4.5° Rotation (make sure to use the side labelled «RIGHT» on the right knee and the side labelled «LEFT» on the left knee).

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Distal femoral cut

•��Place�the�Distal�Resection�Guide�on�the�Headless�Pins�in�the�0�mm�position,�against�the�femoral�trochlea.

•�Check�the�cut�thickness�with�the�Resection�Gauge.

•�Use�two�other�converging�Pins�to�stabilise�the�Distal�Resection�Guide.

•��Perform�the�distal�cut�using�a�Medium�AMPLITUDE�Saw�Blade�that�matches�the�instrumentation�set�and�Motorized�Handpiece.

•�Extract�the�converging�Pins�with�the�Handpiece�or�Pin�Extractor.

•��Slide�the�Distal�Resection�Guide�off�the�Pins�in�the�0�holes,�but�leave�the�Pins�in�place�in�case�recutting�is�necessary.

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-1�mm

+1�mm O�mmReference

mark

OPTION 1 :4-in-1 femoral cuts using the i.M.A.G.E.® System

•�Put�the�Headless�Pins�back�in�the�distal�holes�that�were�marked�with�methylene�blue.

•��Place�the�4-in-1�Femoral�Resection�Guide�corresponding�to�the�planned�size�on�the�distal�Pins�in�the�middle�holes�(neutral�position).

NOTE: At this step the femoral size can still be changed. Place the choosen 4-in-1 Femoral Resection Guide on the Pins:- With a larger size, the posterior cut is unchanged but the anterior cut will be 2.6 mm smaller.- With a smaller size, the posterior cut is unchanged but the anterior cut will be 2.6 mm larger.

•�Make�sure�the�4-in-1�Femoral�Resection�Guide�is�flush�with�the�distal�cut.

•�Use�the�Resection�Gauge�to�ensure�the�anterior�resection�will�respect�the�anterior�cortex.

•��If�the�femoral�cuts�need�to�be�adjusted�in�the�anteroposterior�direction,�shift�the�4-in-1�Femoral�Resection�Guide�on�the�distal�Pins�by�placing�it�in�the�lower�holes�(flexion�gap�increased�by�1�mm)�or�upper�holes�(flexion�gap�reduced�by�1�mm).

•�Secure�the�Resection�Guide�with�2�lateral�Headless�Pins�or�Collared�Threaded�Pins.

•��In�patients�with�osteoporosis,�better�fixation�can�be�achieved�by�adding�a�Pin�in�the�intercondylar�notch,�connect�the�two�Handles�on�the�Resection�Guide.

•��Make�the�anterior�and�posterior�cuts�using�a�Medium�AMPLITUDE�Saw�Blade�that�matches�the�instrumentation�set�and�Motorized�Handpiece.

•�Remove�the�distal�Pins�using�the�Pin�Extractor.

•�Make�the�2�chamfer�cuts.

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26 27

OPTION 2:Ligament Balancer + 4-in-1 Pin Positioner

Extension gap measurement Ligament balancing while in extension:

This�step�is�carried�out�after�performing�the�distal�femoral�and�tibial�cuts.�The�goal�is�to�achieve�a�rectangular�gap�in�extension�when�the�ligaments�are�under�tension.�The�resulting�gap�will�be�measured�and�should�be�the�same�when�the�knee�flexed.

•�Insert�the�ligament�balancer�into�the�knee�joint�with�the�knee�extended.

•�Insert�the�H5�ratcheting�screwdriver�into�the�balancer’s�cog�wheel.

•��Turn�the�H5�screwdriver�to�operate�the�distraction�mechanism�and�apply�the�desired�amount�of�tension.�Do�not�apply�excessive�distraction,�otherwise�the�knee�will�flex.�The�knee�must�stay�extended�during�the�measurements.

•��Make�sure�the�tibial�and�distal�femoral�cuts�are�parallel,�and�check�the�height�of�the�tibiofemoral�gap.

•��If�the�tibiofemoral�gap�is�less�than�the�18�mm�minimum�gap�needed�(10�mm�for�the�tibial�component�plus�8�mm�for�the�femoral�component),�redo�the�tibial�or�distal�femoral�cut.

Note:�Ligaments�can�be�released�to�achieve�desired�ligament�balance�(value�of�0�on�balancer).

•�Press�the�blue�unlock�button�to�remove�the�balancer�from�the�joint.

Important:�remove�the�2�headless�pins�left�in�anterior�part.

�Read�degrees�here�to�verify�the�

�cuts�are�parallel�to�each�other�

Read�extension�gap�here�(mm)�������

Minimum�gap�in�extension:��18�mm�=�10�mm�(tibial�component)�+�8�mm�(femoral�component)

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28 29

}

OPTION 2:Ligament Balancer + 4-in-1 Pin Positioner

Transfer of gap into flexion

•�Flex�the�knee.

•�Insert�the�balancer�and�apply�the�desired�tension�(same�procedure�as�with�knee�extended).

•��Read�the�flexion�gap�value�and�femur�rotation�value�(induced�by�ligament�laxity)�relative�to�the�tibia.

•��Make�sure�the�flexion�gap�is�equal�to�the�extension�gap�(8�mm�must�be�subtracted�from�the�extension�gap�value).

On�the�back�table:�������

•�Set�the�femoral�rotation�based�on�the�measurement�taken�with�the�balancer.

•�If�the�flexion�gap�is�equal�to�the�extension�gap,�set�the�posterior�plate�position�to�0�mm.

•��If�the�flexion�gap�is�larger�than�the�extension�gap,�set�the�posterior�plate�position�to�-2�mm�to�reduce�the�posterior�gap�by�2�mm.

•��If�the�flexion�gap�is�smaller�than�the�extension�gap,�set�the�posterior�plate�position�to�+2�mm�to�increase�the�posterior�gap�by�2�mm.

Note:�The�pin�positioner�uses�a�posterior�reference�point.

•�Mount�the�femoral�probe.

Read�flexion�gap�here(Subtract�8�mm�from�

extension�gap)

Set�femoral��rotation�here

The�distal�pins�can�be�offset�by�+2�mm�

or�-2�mm�in�the�anteroposterior�

direction

2�ML�positions�of�probe

Anterior�cut�height�by�

Femur�size���(Verify�with�

resection�gauge)

Read�femoral�component�size�here

Read�femoral�rotation�here

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30 31

OPTION 2:Ligament Balancer + 4-in-1 Pin Positioner

Distal pin insertion

On�the�patient:������

•��Remove�the�balancer�and�place�the�pin�positioner�while�making�sure:�� -�it�is�flush�with�the�distal�cut�and� -�it�rests�against�the�posterior�condyles

•�Place�the�probe�tip�against�the�anterior�cortex�and�determine�the�femoral�component�size.

•�Verify�the�size�by�placing�the�resection�gauge�into�the�slots�to�preview�the�anterior�cut�position.

•�If�the�femoral�size�shown�is�between�two�sizes,�the�distal�pins�can�be�offset:� -��Position�+2�mm:�Femoral�component�position�will�be�offset�by�2�mm�anteriorly�(posterior�

gap�is�2�mm�larger,�anterior�cut�is�2�mm�higher)�� -��Position�-2�mm:�Femoral�component�position�will�be�offset�by�2�mm�posteriorly�(posterior�

gap�is�2�mm�smaller,�anterior�cut�is�2�mm�lower)�

•�Insert�the�distal�pins�(diameter�3,2�mm,�length�65�mm).

•�Remove�the�pin�positioner.

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32 33

-1�mm

+1�mm

OPTION 2:Ligament Balancer + 4-in-1 Pin Positioner

Femoral cuts using the 4-in-1 instrumentation

•��Set�the�4-in-1�resection�guide�that�corresponds�to�the�measured�size�on�the�distal�pins�in�the�middle�holes�(neutral�position).

•�Make�sure�side�of�the�resection�guide�is�flush�with�the�distal�cut.

•��Use�the�resection�gauge�to�check�the�anterior�cut�will�not�notch�the�femoral�cortex�is�intact.

•��If�the�femoral�cuts�need�to�be�adjusted�in�the�anteroposterior�direction,�set�the�4-in-1�resection�guide�on�the�distal�pins�in�either�the�lower�holes�(flexion�gap�increased�by�+1mm)�or�the�upper�holes�(flexion�gap�decreased�by�-1�mm).

•�Secure�the�sides�of�the�resection�guide�with�headless�pins�or�collared�threaded�pins.

•��In�patients�with�osteoporosis,�better�fixation�can�be�achieved�by�adding�a�pin�in�the�intercondylar�notch,�connect�the�two�handles�on�the�cutting�guide�for�better�hold�while�inserting�the�pins.

•��Make�the�anterior�and�posterior�cuts�using�a�medium�AMPLITUDE®�saw�blade�that�matches�the�instrumentation�set�and�motorized�handpiece.

•�Remove�the�distal�pins�using�the�pin�extractor.

•�Make�the�2�chamfer�cuts.

Optional�pin�into�intercondylar�notch

0Reference�

mark

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34 35

Left�knee

Line�indicating�the�centre�of�the�femoral�preparation�guide

Femoral notch preparation

•�Select�the�same�size�of�notch�reamer�as�the�preparation�guide.

•�Push�the�reamer�into�the�guide�until�it�stops.

Femoral preparation guide placement

•��Choose�the�same�size�of�femoral�preparation�guide�as�the�4-in-1�resection�guide�used�previously.

•��Place�the�universal�handle�on�the�oval�clip�by�simultaneously�pushing�and�turning�the�handle�one-quarter�turn.

•��Place�the�femoral�preparation�guide�onto�the�femur.�This�guide�has�the�same�mediolateral�dimensions�as�the�replacement�femoral�component.�Use�the�two�windows�on�the�anterior�face�to�help�position�the�guide:�

� -��The�outer�(lateral)�side�of�the�guide�corresponds�to�the�outer�edge�of�the�replacement�femoral�component

� -��The�inner�(medial)�side�of�the�window�corresponds�to�the�inner�edge�of�the�replacement�femoral�component�(see�figure�on�opposite�page)

•��The�guide�can�be�centred�in�the�medio-lateral�direction�by�aligning�the�line�at�the�centre�of�the�guide�over�the�posterior�intercondylar�notch.

•�Secure�the�femoral�preparation�guide�with�three�headed�pins.

•�Remove�the�universal�handle.

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36 37

Postero-stabilisation cam preparation

•�Assemble�the�L-shaped�chisel�with�the�universal�handle.

•��Prepare�the�postero-stabilisation�cam�space�by�pushing�the�L-shaped�chisel�into�each�side�of�the�guide�area.�Impact�the�chisel�until�it�reaches�the�line�corresponding�to�the�size�of�the�guide�being�used�(guide�entrance).

•��Mark�the�entry�point�for�the�two�pegs�with�the�drill�bit�with�stop�while�making�sure�the�bit�is�well-aligned�with�the�pegs.

Note:�The�pegs�can�be�prepared�on�the�trial�femoral�component.

Femoral trochlea preparation

•��Select�the�trochlear�box�chisel�corresponding�to�the�operated�side�and�assemble�it�with�the�universal�handle.

•�Prepare�the�trochlea�by�inserting�the�box�chisel�into�the�guide.

Important:�Make�sure�the�box�chisel�is�properly�oriented�from�top�to�bottom.

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38 39

Placement of trial femoral component

•��Select�the�appropriate�side�and�size�of�trial�femoral�component.

•��Impact�the�trial�femoral�component�using�the�holder,�adjusting�the�medio-lateral�position�as�needed.

Note: If�all�the�femoral�peg�holes�have�already�been�made,�place�the�trial�pegs�into�the�trial�femoral�component�before�connecting�it�to�the�holder.�This�will�make�it�easier�to�achieve�the�correct�medio-lateral�position�during�impaction.

•��Finish�impacting�the�trial�component�using�the�femoral�component�impactor�and�universal�handle.

•�If�the�peg�holes�were�not�prepared�using�the�femoral�preparation�guide:� -�Use�the�drill�bit�with�stop�to�make�first�peg�pilot�hole� -�Insert�the�trial�peg� -�Make�the�second�peg�pilot�hole� -�Insert�the�second�trial�peg

•��Any�posterior�osteophytes�can�be�removed�using�the�osteotome�that�matches�the�trial�femoral�component�size.

Final femoral preparation

•�To�remove�the�bone�ridge�between�the�distal�cut�and�reamed�notch:�� -�Select�an�osteotome�of�the�same�size�as�the�preparation�guide� -��Push�the�osteotome�into�each�of�the�two�slots�on�the�outside�of�the�reamer�hole�until�it�

stops,�make�sure�the�«NOTCH�SIDE»�label�faces�the�notch�when�pushing�in�the�osteotome

Note:�If�the�osteotome�is�difficult�to�pull�out,�place�the�T�end�of�the�slap-hammer�into�the�hole.��

•��Remove�the�3�headed�pins�using�the�pin�extractor�and�extract�the�preparation�guide�using�the�universal�handle.

Site�for�osteotome

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40 41

Preparation of tibial anchoring points

•��Put�the�assembled�femoral�and�tibial�trial�components�through�a�flexion�/�extension�cycle�to�asses�joint�balance�and�allow�the�baseplate�to�seat�itself�in�the�appropriate�rotation�(the�handle�can�be�removed).

•�Pick�a�different�insert�height�if�needed.

•��Use�electocautery�to�mark�the�baseplate�position�on�the�tibia�using�the�two�lines�on�the�baseplate.

•��Remove�the�assembled�tibial�components�and�replace�the�baseplate�(without�the�insert)�using�the�marks�made�on�the�tibia�as�a�guide.

•�Secure�the�baseplate�with�two�30�mm�headed�pins.

Placement of trial tibial baseplate

•��Confirm�the�size�of�the�planned�tibial�baseplate.�The�baseplate�can�be�the�same,�or�one�size�larger�or�smaller�than�the�size�fo�the�femoral�component.

•�Position�the�trial�tibial�baseplate�onto�the�tibial�cut.�The�tibial�baseplate�handle�can�be�used.

•��Once�the�size�has�been�selected,�remove�the�baseplate�handle,�place�the�same�size�of�insert�and�reattach�the�baseplate�handle.�The�lugs�on�the�handle�help�secure�the�insert�to�the�trial�baseplate.�In�addition,�the�handle�can�be�used�with�an�extramedullary�alignment�rod�to�verify�the�rotation,�slope�and�perpendicular�alignment�of�the�tibial�cut.�

Important:�remove�the�2�headless�pins�left�in�the�tibia.

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42 43

Tibial preparation

•�Place�the�tibial�fins�punch�guide�onto�the�trial�baseplate�and�verify�that�the�sizes�are�compatible.

•��Handles�can�be�secured�to�the�sides�of�the�tibial�fins�punch�guide�to�stabilise�the�entire�assembly�during�the�various�preparation�steps.

•�With�the�power�tool,�drive�the�tibial�keel�drill�bit�into�the�guide�until�it�stops.

•��Prepare�the�fins�by�pushing�the�appropriately�sized�tibial�fin�punch�(assembled�with�the�universal�handle)�until�it�stops.

•�Remove�all�the�instruments�using�the�baseplate�handle�and�the�pin�extractor.

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44 45

Patellar preparationPatellar reaming option

•�Trim�away�any�peripheral�osteophytes.

•��Centre�the�trial�inset�patella�on�the�central�ridge�of�the�articular�surface�of�the�native�patella.�������The�appropriate�size�(Ø�23,�26�or�29�mm)�is�determined�based�on�the�following�criteria:

� -�Superior-to-inferior�length�of�the�articular�surface� -�Width�of�the�patella’s�medial�articular�facet�� -��The�size�must�be�slightly�smaller�(by�about�2�mm)�than�the�superior-to-inferior�length�of�the�

articular�surface�and�must�be�slightly�inside�the�medial�edge�of�the�medial�articular�facet

•��Assemble�the�clamp�corresponding�to�the�chosen�patellar�implant�size�onto�the�locking�patellar�reaming�forceps�and�lock�it�into�place.

•��Position�the�forceps.�The�inferior�jaw�on�the�reaming�forceps�must�rest�against�the�anterior�side�of�the�patella.�The�clamp�must�rest�against�at�least�one�of�the�patella’s�two�articular�facets.�����

•�Use�the�thumb�knob�to�tighten�the�reaming�forceps.

•��Assemble�the�reamer�for�inset�patella�of�the�same�size�as�the�chosen�clamp�onto�the�power�tool.

•�Ream�the�patella�until�the�stop�is�reached.

•��Use�the�clamp�for�trial�patella�to�place�the�trial�cemented�patellar�implant�of�the�selected�size�into�the�native�patella.

•�Test�the�articulation�of�the�patella�in�the�trochlea.

•��Assemble�the�patella�binding�clamp�onto�the�locking�patellar�reaming�forceps�and�lock�it�into�place.

•�Insert�the�chosen�patellar�component.

Patellar preparationPatellar resection option

After�clearing�the�area�around�the�patella

•�Place�the�clamp�so�the�two�lugs�are�on�the�anterior�side�of�the�patella.

•��With�the�clamp�jaws�open,�bring�the�8�mm�probe�into�contact�with�the�articular�surface�using�the�adjustment�knob.

•�Lock�the�clamp.

•�Evaluate�remaining�bone.

•�Push�the�saw�blade�into�the�slot�to�perform�the�cut.

•��Use�the�drilling�templates�to�determine�the�size�of�patellar�component�needed:�30,�33�or�36�mm.

•�Centre�and�impact�the�drilling�template.

•�Make�the�pilot�holes�for�the�three�pegs.

•�Set�the�trial�patellar�component�into�place�using�the�patellar�clamping�forceps.

•�Test�the�articulation�in�the�trochlea.

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46 47

Insertion of chosen tibial baseplate

•��Use�the�keel�wrench�to�screw�the�distal�peg�into�the�tibial�baseplate�(cemented�or�cementless).

•��Position�the�tibial�baseplate�and�impact�it�using�the�tibial�impactor�mounted�on�the�universal�handle.

Note:��If�the�final�insert�thickness�has�not�be�determined,�a�trial�insert�can�be�placed�onto�the�chosen�tibial�baseplate�for�the�trials.

Insertion of chosen insert

•��At�this�point�in�the�procedure,�trials�can�still�be�performed�with�a�trial�insert�and�the�chosen�tibial�baseplate.

•�Hyperflex�the�knee.

•��Slide�the�insert�onto�the�lateral�baseplate�rails,�and�then�impact�its�anterior�edge�using�the�tibial�impactor.

•�Reduce�the�femoral�component�onto�the�insert.

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48 49

Insertion of chosen femoral component

•��Assemble�the�chosen�femoral�component�(cemented�or�cementless)�with�the�femoral�component�holder.

•��Place�the�femoral�component�onto�the�femoral�cuts,�make�sure�it�is�aligned�precisely,�and�then�impact�it.�Remove�the�femoral�component�holder.

•�Finish�impacting�the�component�using�the�femoral�component�impactor�and�universal�handle.

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50 51

Tibial baseplate extractionRevision cases

•��To�remove�the�tibial�insert,�wedge�a�Lambotte�osteotome�or�bone�chisel�between�the�insert�and�baseplate.

•�Assemble�the�baseplate�extractor�with�the�universal�handle.

•�Screw�them�into�the�tibial�baseplate.

•�Gradually�extract�the�component�by�tapping�under�the�anvil.

Note:�The�slap-hammer�can�be�assembled�with�the�universal�handle�to�make�the�extraction�easier.

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52 53

1 2 3 4

The i.M.A.G.E.® 4-in-1 instrumentation for the ANATOMIC® TKA requires:

An i.M.A.G.E.® 4-in-1 kit for TKA

The additional set - i.M.A.G.E.® 4-in-1 for TKA

The 4-in-1 ANATOMIC® conventional instrumentation composed of 6 trays:� One�common� One�for�tibial�resection� One�for�tibial�trials�� One�for�4-in-1�femoral�resections�� One�for�femoral�preparation� One�for�femoral�trialsAnd either of:� One�for�patellar�resection� One�for�patellar�reaming

In addition:� One�optional�set�for�Size�0�and�Size�8�� Sterile�large�saw�blades� Sterile�medium�saw�blades

Composition of the instrumentation i.M.A.G.E. ® 4-in-1 kit for TKA

Item Name Product No. Qtyi.M.A.G.E.® F and T Pin Positioning Guides with Phantoms,TKA – 4-in-1, MRI Version – Non Sterile

9-0200410

1i.M.A.G.E.®�Femoral�Pin�Positioning�Guide,�TKA�–�4-in-1,MRI�Version�–�NS

- 1

2i.M.A.G.E.®�Tibial�Pin�Positioning�Guide,�TKA�–�4-in-1,MRI�Version�–�NS

- 1

3 i.M.A.G.E.®�Femur�Phantom,�TKA - 14 i.M.A.G.E.®�Tibia�Phantom,�TKA - 1

i.M.A.G.E.® F and T Pin Positioning Guides with Phantoms,TKA – 4-in-1, CT Scan Version – Non Sterile

9-0200430

1i.M.A.G.E.®�Femoral�Pin�Positioning�Guide,�TKA�–�4-in-1,CT�scan�Version�–�NS

- 1

2i.M.A.G.E.®�Tibial�Pin�Positioning�Guide,�TKA�–�4-in-1,CT�scan�Version�–�NS

- 1

3 i.M.A.G.E.®�Femur�Phantom,�TKA - 14 i.M.A.G.E.®�Tibia�Phantom,�TKA - 1

i.M.A.G.E.® F and T Pin Positioning GuidesTKA – 4-in-1, MRI Version – Non Sterile

9-0200400

1i.M.A.G.E.®�Femoral�Pin�Positioning�Guide,�TKA�–�4-in-1,MRI�Version�–�NS

- 1

2i.M.A.G.E.®�Tibial�Pin�Positioning�Guide,�TKA�–�4-in-1,MRI�Version�–�NS

- 1

i.M.A.G.E.® F and T Pin Positioning Guides,TKA – 4-in-1, CT scan Version – Non Sterile

9-0200420

1i.M.A.G.E.®�Femoral�Pin�Positioning�Guide,�TKA�–�4-in-1,CT�scan�Version�–�NS

- 1

2i.M.A.G.E.®�Tibial�Pin�Positioning�Guide,�TKA�–�4-in-1,CT�scan�Version�–�NS

- 1

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54 55

1

23

24

14

1617

18 19

22

2115

20

255

2-3

6

413

7 8 91012

11

Item Name Product No Qty

1 Removable�Tibial�and�4-in-1�Distal�Femoral�Pin�Guide�i.M.A.G.E.® 2-0228800 1

2 Removable�4-in-1�Femoral�Pin�Guide�+0°�Rotation�i.M.A.G.E.® 2-0228701 13 Removable�4-in-1�Femoral�Pin�Guide�+1.5°�Rotation�i.M.A.G.E.® 2-0228702 14 Removable�4-in-1�Femoral�Pin�Guide�+3°�Rotation�i.M.A.G.E.® 2-0228703 15 Removable�4-in-1�Femoral�Pin�Guide�+4.5°�Rotation�i.M.A.G.E.® 2-0228704 1

Additional set - i.M.A .G.E.® 4-in-1 for TKA Common Set

Item Name Product No. Qty

1 Intramedullary�drill�bit 2-0200100 1

2 Intramedullary�rod�-�length�250�mm 2-0200200 13 Intramedullary�rod�-�length�400�mm 2-0200300 14 Universal�T-handle 2-0200400 15 Universal�handle 2-0216400 16 Extramedullary�alignment�rod 2-0200600 27 Spacer�-�height�7�mm 2-0200707 18 Spacer�-�height�10�mm 2-0200710 19 Spacer�-�height�18�mm 2-0200718 110 Augment�-�height�2�mm�for�spacer 2-0207002 111 Augment�-�height�4�mm�for�spacer 2-0207004 112 H5�Screwdriver 2-0200800 113 Resection�gauge 2-0204500 114 Blunt�K-wire,�diam.�2�mm,�length�150�mm 2-0103000 215 Alignment�gauge 2-0206300 116 Universal�connector�for�self-drilling�K-wire 2-0201100 117 AO�connector�for�self-drilling�K-wire 2-0201200 118 Pin�extractor 2-0201500 119 Wrench�for�keel 2-0205500 120 Drill�bit,��3.2,�length�145�mm 2-0102400 121 Slaphammer 2-0206900 122 Flat�rasp 2-0206800 123 Hohmann�retractor�240�mm�18�mm 2-0207100 224 Hohmann�retractor�265�mm�24�mm 2-0207200 1�25 Tibial�baseplate�handle 2-0223500 1�

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Tibial Trials SetTibial Resection Set

Item Name Product No. Qty

1 Trial�tibial�baseplate,�posterior-stabilised�-�Size�1 2-0231001 1

2 Trial�tibial�baseplate,�posterior-stabilised�-�Size�2 2-0231002 13 Trial�tibial�baseplate,�posterior-stabilised�-�Size�3 2-0231003 14 Trial�tibial�baseplate,�posterior-stabilised�-�Size�4 2-0231004 15 Trial�tibial�baseplate,�posterior-stabilised�-�Size�5 2-0231005 16 Trial�tibial�baseplate,�posterior-stabilised�-�Size�6 2-0231006 17 Trial�tibial�baseplate,�posterior-stabilised�-�Size�7 2-0231007 18 Trial�fixed�insert,�posterior-stabilised�-�Size�1,�Height�10 2-0230610 18 Trial�fixed�insert,�posterior-stabilised�-�Size�1,�Height�12 2-0230611 18 Trial�fixed�insert,�posterior-stabilised�-�Size�1,�Height�14 2-0230612 18 Trial�fixed�insert,�posterior-stabilised�-�Size�1,�Height�16 2-0230613 18 Trial�fixed�insert,�posterior-stabilised�-�Size�1,�Height�18 2-0230614 18 Trial�fixed�insert,�posterior-stabilised�-�Size�1,�Height�20 2-0230615 19 Trial�fixed�insert,�posterior-stabilised�-�Size�2,�Height�10 2-0230620 19 Trial�fixed�insert,�posterior-stabilised�-�Size�2,�Height�12 2-0230621 19 Trial�fixed�insert,�posterior-stabilised�-�Size�2,�Height�14 2-0230622 19 Trial�fixed�insert,�posterior-stabilised�-�Size�2,�Height�16 2-0230623 19 Trial�fixed�insert,�posterior-stabilised�-�Size�2,�Height�18 2-0230624 19 Trial�fixed�insert,�posterior-stabilised�-�Size�2,�Height�20 2-0230625 110 Trial�fixed�insert,�posterior-stabilised�-�Size�3,�Height�10 2-0230630 110 Trial�fixed�insert,�posterior-stabilised�-�Size�3,�Height�12 2-0230631 110 Trial�fixed�insert,�posterior-stabilised�-�Size�3,�Height�14 2-0230632 110 Trial�fixed�insert,�posterior-stabilised�-�Size�3,�Height�16 2-0230633 110 Trial�fixed�insert,�posterior-stabilised�-�Size�3,�Height�18 2-0230634 110 Trial�fixed�insert,�posterior-stabilised�-�Size�3,�Height�20 2-0230635 1

Item Name Product No. Qty

1 Malleolar�clamp 2-0201600 1

2 Extramedullary�alignment�guide 2-0201700 13 Thumb�knob�for�extramedullary�alignment�guide 2-0201800 24 Tibial�slide�bar 2-0201900 15 Tibial�bracket 2-0202000 16 Thumb�knob�for�tibial�bracket 2-0202100 17 Headed�pin�-�length�30�mm 2-0201301 68 Headed�pin�-�length�70�mm 2-0201302 39 Headless�pin 2-0201400 610 Tibial�resection�guide�-�Right 2-0202200 111 Tibial�resection�guide�-�Left 2-0202300 112 Thumb�knob�for�resection�guide 2-0203800 213 Tibial�stylus 2-0202400 114 Guide�for�tibial�fin�punch�-�Size�0/1/2 2-0230801 115 Guide�for�tibial�fin�punch�-�Size�3/4/5 2-0230802 116 Guide�for�tibial�fin�punch�-�Size�6/7/8 2-0230803 117 Removable�handle 2-0226500 218 Reamer�for�tibial�keel 2-0231600 119 Tibial�fin�punch�-�Size�0/1/2 2-0230901 120 Tibial�fin�punch�-�Size�3/4/5 2-0230902 121 Tibial�fin�punch�-�Size�6/7/8 2-0230903 122 Universal�Handle 2-0232100 123 Tibial�impactor 2-0231900 124 Tibial�baseplate�extractor 2-0231800 125 Jig�support�for�baseplate�handle 2-0223600 126 Baseplate�impactor 2-0233400 1

Page 30: Surgical Technique i.M.A.G.E. Patient Specific ...® Patient Specific Instrumentation 4-in-1. 2 3 ... • Patient-specific instrumentation is designed according to the ... osteotomy

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Ref :

INDICE

Constitution Ancillaire pour

4Prothèse Totale de Genou Instumentation 4 en 1

Positionneur de clous

(Version Mécanique)

2-0299941 14/06/2016Date de début d'effet :

Plateau N°1

Rep Désignation Ref Qté

2-0226401Guide de coupe fémorale 4 en 1 Taille 11 1

2-0226402Guide de coupe fémorale 4 en 1 Taille 21 1

2-0226403Guide de coupe fémorale 4 en 1 Taille 31 1

2-0226404Guide de coupe fémorale 4 en 1 Taille 41 1

2-0226405Guide de coupe fémorale 4 en 1 Taille 51 1

2-0226406Guide de coupe fémorale 4 en 1 Taille 61 1

2-0226407Guide de coupe fémorale 4 en 1 Taille 71 1

2-0226500Poignée amovible2 2

2-0233200"Tenseur Extra articulaire à Bascule ""BALANCEUR"" v2"3 1

2-0225500Tournevis H3.54 1

2-0204400Préhenseur de condyle fémoral5 1

2-0201402Clou sans tête D3.2 mm longueur 65 mm6 6

2-0229900Palpeur 4 en 17 1

2-0229800Positionneur de clous 4 en 18 1

2-0226900Guide de coupe distale 8 mm9 1

2-0228900Guide coupe distale 10 mm9 1

2-0226800Coulisse distale10 1

2-0226600Canon valgus réglable 0°11 1

2-0226603Canon valgus réglable 3°11 1

2-0226606Canon valgus réglable 6°11 1

2-0228200Clé H2.512 1

2-0233100Tournevis encliquetable H513 1

2-0238857Broche filetée à collerette Ø3,2-L5714 2

3-0201618 1Plateau Inox aménagé PTG Instrumentation 4 en 1 - Positionneur de clous

3-0201717 1Couvercle pour plateau Inox aménagé PTG Instrumentation 4 EN 1 - Positionneur de Clous

3-0100901 1Container protégé Medlane alu 2 Filtres 600x300x210 ROUGE

3-0100205-31 1Etiquette Medlane alu ROUGE - GRAVEE PTG SCORE COUPE FEMORALE POSITIONNEUR DE

CLOU

3-0100204-1 1Etiquette Medlane alu GRISE - GRAVEE x 1

Ce document est la propriété de la société AMPLITUDE.

Il ne peut être reproduit ou communiqué sans son autorisation Page 1 sur 2DS.014/04

1 9 11 133 5 7

28 10 12 144 6

Tibial Trials Set

Item Name Product No. Qty

11 Trial�fixed�insert,�posterior-stabilised�-�Size�4,�Height�10 2-0230640 1

11 Trial�fixed�insert,�posterior-stabilised�-�Size�4,�Height�12 2-0230641 111 Trial�fixed�insert,�posterior-stabilised�-�Size�4,�Height�14 2-0230642 111 Trial�fixed�insert,�posterior-stabilised�-�Size�4,�Height�16 2-0230643 111 Trial�fixed�insert,�posterior-stabilised�-�Size�4,�Height�18 2-0230644 111 Trial�fixed�insert,�posterior-stabilised�-�Size�4,�Height�20 2-0230645 112 Trial�fixed�insert,�posterior-stabilised�-�Size�5,�Height�10 2-0230650 112 Trial�fixed�insert,�posterior-stabilised�-�Size�5,�Height�12 2-0230651 112 Trial�fixed�insert,�posterior-stabilised�-�Size�5,�Height�14 2-0230652 112 Trial�fixed�insert,�posterior-stabilised�-�Size�5,�Height�16 2-0230653 112 Trial�fixed�insert,�posterior-stabilised�-�Size�5,�Height�18 2-0230654 112 Trial�fixed�insert,�posterior-stabilised�-�Size�5,�Height�20 2-0230655 113 Trial�fixed�insert,�posterior-stabilised�-�Size�6,�Height�10 2-0230660 113 Trial�fixed�insert,�posterior-stabilised�-�Size�6,�Height�12 2-0230661 113 Trial�fixed�insert,�posterior-stabilised�-�Size�6,�Height�14 2-0230662 113 Trial�fixed�insert,�posterior-stabilised�-�Size�6,�Height�16 2-0230663 113 Trial�fixed�insert,�posterior-stabilised�-�Size�6,�Height�18 2-0230664 113 Trial�fixed�insert,�posterior-stabilised�-�Size�6,�Height�20 2-0230665 114 Trial�fixed�insert,�posterior-stabilised�-�Size�7,�Height�10 2-0230670 114 Trial�fixed�insert,�posterior-stabilised�-�Size�7,�Height�12 2-0230671 114 Trial�fixed�insert,�posterior-stabilised�-�Size�7,�Height�14 2-0230672 114 Trial�fixed�insert,�posterior-stabilised�-�Size�7,�Height�16 2-0230673 114 Trial�fixed�insert,�posterior-stabilised�-�Size�7,�Height�18 2-0230674 114 Trial�fixed�insert,�posterior-stabilised�-�Size�7,�Height�20 2-0230675 1

4-in-1 Femoral Resection Set

Item Name Product No. Qty

1 4-in-1�Femoral�resection�guide�-�Size�1 2-0226401 1

1 4-in-1�Femoral�resection�guide�-�Size�2 2-0226402 11 4-in-1�Femoral�resection�guide�-�Size�3� 2-0226403 11 4-in-1�Femoral�resection�guide�-�Size�4 2-0226404 11 4-in-1�Femoral�resection�guide�-�Size�5 2-0226405 11 4-in-1�Femoral�resection�guide�-�Size�6 2-0226406 11 4-in-1�Femoral�resection�guide�-�Size�7 2-0226407 12 Removable�handle 2-0226500 23 V2�Extra-articular�ligament�balancer� 2-0233200 14 H3.5�Screwdriver 2-0225500 15 Femoral�component�holder 2-0204400 16 Headless�pin,�Ø�3.2�length�65�mm 2-0201402 67 4-in-1�probe 2-0229900 18 4-in-1�pin�positioner 2-0229800 19 Distal�resection�guide�-�8�mm 2-0226900 19 Distal�resection�guide�-�10�mm 2-0228900 110 Distal�slide�bar 2-0226800 111 Adjustable�valgus�barrel�0° 2-0226600 111 Adjustable�valgus�barrel�3° 2-0226603 111 Adjustable�valgus�barrel�6° 2-0226606 112 H2.5�Wrench 2-0228200 113 H5�ratcheting�screwdriver� 2-0233100 114 Collared�threaded�pin,�Ø�3.2�length�57�mm� 2-0238857 2

Page 31: Surgical Technique i.M.A.G.E. Patient Specific ...® Patient Specific Instrumentation 4-in-1. 2 3 ... • Patient-specific instrumentation is designed according to the ... osteotomy

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3-45

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2

1

2

3

4

5

6

7

8

Femoral Trials Set

Item Name Product No. Qty

1 Trial�femoral�component,�posterior-stabilised�-�Size�1�Right 2-0231101 1

1 Trial�femoral�component,�posterior-stabilised�-�Size�2�Right 2-0231102 11 Trial�femoral�component,�posterior-stabilised�-�Size�3�Right 2-0231103 11 Trial�femoral�component,�posterior-stabilised�-�Size�4�Right 2-0231104 11 Trial�femoral�component,�posterior-stabilised�-�Size�5�Right 2-0231105 11 Trial�femoral�component,�posterior-stabilised�-�Size�6�Right 2-0231106 11 Trial�femoral�component,�posterior-stabilised�-�Size�7�Right 2-0231107 12 Trial�femoral�component,�posterior-stabilised�-�Size�1�Left 2-0231201 12 Trial�femoral�component,�posterior-stabilised�-�Size�2�Left 2-0231202 12 Trial�femoral�component,�posterior-stabilised�-�Size�3�Left 2-0231203 12 Trial�femoral�component,�posterior-stabilised�-�Size�4�Left 2-0231204 12 Trial�femoral�component,�posterior-stabilised�-�Size�5�Left 2-0231205 12 Trial�femoral�component,�posterior-stabilised�-�Size�6�Left 2-0231206 12 Trial�femoral�component,�posterior-stabilised�-�Size�7�Left 2-0231207 13 Osteotome 2-0206500 14 UNI�Osteotome 2-0221500 15 Femoral�component�impactor 2-0233500 16 PS�Femoral�component�holder 2-0232000 17 Trial�peg�for�trial�femoral�component,�without�navigation 2-0233300 2

Femoral Preparation Set

Item Name Product No. Qty

1 Notch�reamer�-�Size�1 2-0231301 1

1 Notch�reamer�-�Size�2 2-0231302 11 Notch�reamer�-�Size�3 2-0231303 11 Notch�reamer�-�Size�4 2-0231304 11 Notch�reamer�-�Size�5 2-0231305 11 Notch�reamer�-�Size�6 2-0231306 11 Notch�reamer�-�Size�7 2-0231307 12 Femoral�preparation�guide�-�Size�1 2-0230701 12 Femoral�preparation�guide�-�Size�2 2-0230702 12 Femoral�preparation�guide�-�Size�3 2-0230703 12 Femoral�preparation�guide�-�Size�4 2-0230704 12 Femoral�preparation�guide�-�Size�5 2-0230705 12 Femoral�preparation�guide�-�Size�6 2-0230706 12 Femoral�preparation�guide�-�Size�7 2-0230707 13 Drill�bit�for�femoral�peg 2-0204000 14 PS�cam�box�chisel 2-0231700 15 Trochlea�box�chisel�-�Right 2-0231400 16 Trochlea�box�chisel�-�Left 2-0231500 17 Universal�Handle 2-0232100 18 Osteotome�-�Size�0/1/2 2-0233700 18 Osteotome�-�Size�3/4/5 2-0233701 18 Osteotome�-�Size�6/7/8 2-0233702 1

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3

4

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8

9

101

1

4

3

212

56

7

8

9

10

11 13

14

15

Patellar Reaming SetPatellar Resection Set

Item Name Product No. Qty

1 Patellar�reaming�forceps 2-0216600 1

2 Reamer�for�cementless�inset�patella��23 2-0216523 13 Reamer�for�cementless�inset�patella��26 2-0216526 14 Reamer�for�cementless�inset�patella��29 2-0216529 15 Binding�clamp�for�cementless�inset�patella 2-0216800 16 Clamp�for�patellar�reaming�forceps��23 2-0216723 17 Clamp�for�patellar�reaming�forceps��26 2-0216726 18 Clamp�for�patellar�reaming�forceps��29 2-0216729 19 Trial�inset�patellar�implant�-�cemented��23�mm 2-0205223 110 Trial�inset�patellar�implant�-�cemented��26�mm 2-0205226 111 Trial�inset�patellar�implant�-�cemented��29�mm 2-0205229 112 Clamp�for�trial�patella 2-0104600 113 Trial�inset�patellar�implant�-�cementless��29 2-0216929 114 Trial�inset�patellar�implant�-�cementless��26 2-0216926 115 Trial�inset�patellar�implant�-�cementless��23 2-0216923 1

Item Name Product No. Qty

1 Patellar�resection�forceps 2-0206700 1

2 Patellar�resection�gauge 2-0208400 13 Drilling�template��30 2-0204900 14 Drilling�template��33�and��36 2-0205000 15 Drill�bit�for�onset�patella 2-0205100 16 Trial�onset�patella��30 2-0205330 17 Trial�onset�patella��33 2-0205333 18 Trial�onset�patella��36 2-0205336 19 Clamp�for�trial�patella 2-0104600 110 Patellar�clamping�forceps 2-0206100 1

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3

4

5

12

11

10

9

8

7

6 18

19

20

21

22

23

24

15

17

1613

14

Optional Set - Size 0 and Size 8

Item Name Product No. Qty

1 Femoral�preparation�guide�-�Size�0 2-0230700 1

2 Notch�reamer�-�Size�0 2-0231300 13 4-in-1�Femoral�resection�guide�-�Size�0 2-0226400 14 Trial�ANATOMIC®�femoral�component,�posterior-stabilised�-�Size�0�Left 2-0231200 15 Trial�ANATOMIC®�femoral�component,�posterior-stabilised�-�Size�0�Right 2-0231100 16 Trial�ANATOMIC®�tibial�baseplate,�posterior-stabilised�-�Size�0 2-0231000 17 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�0,�Height�10�mm 2-0230601 18 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�0,�Height�12�mm 2-0230602 19 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�0,�Height�14�mm 2-0230603 110 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�0,�Height�16�mm 2-0230604 111 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�0,�Height�18�mm 2-0230605 112 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�0,�Height�20�mm 2-0230606 113 Femoral�preparation�guide�-�Size�8 2-0230708 114 Notch�reamer�-�Size�8 2-0231308 115 4-in-1�Femoral�resection�guide�-�Size�8 2-0226408 116 Trial�ANATOMIC®�femoral�component,�posterior-stabilised�-�Size�8�Right 2-0231108 117 Trial�ANATOMIC®�femoral�component,�posterior-stabilised�-�Size�8�Left 2-0231208 118 Trial�ANATOMIC®�tibial�baseplate,�posterior-stabilised�-�Size�8 2-0231008 119 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�8,�Height�10�mm 2-0230680 120 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�8,�Height�12�mm 2-0230681 121 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�8,�Height�14�mm 2-0230682 122 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�8,�Height�16�mm 2-0230683 123 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�8,�Height�18�mm 2-0230684 124 Trial�ANATOMIC®�fixed�insert,�posterior-stabilised�-�Size�8,�Height�20�mm 2-0230685 1

Medium saw blades

Large saw blades

SYNTHES�AO�/�SODEM�large�saw�blade�Sterile�Product�No.�2-0227901

STRYKER�large�saw�blade�Sterile�Product�No.�2-0227902

ZIMMER�/�HALL�/�LINVATEC�large�saw�blade��Sterile�Product�No.�2-0227903

SYNTHES�AO�/�SODEM�medium�saw�blade��Sterile�Product�No.�2-0228001

STRYKER�medium�saw�blade��Sterile�Product�No.�2-0228002

ZIMMER�/�HALL�/�LINVATEC�medium�saw�blade��Sterile�Product�No.�2-0228003

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Assembly and Disassembly of Balancer Assembly and Disassembly of Pin Positioner

Assembly of Balancer

1 -�Pick�up�the�removable�handle�(4-0238200).

2 -�Screw�the�removable�handle�onto�the�tibial�housing�(4-0237900).

3 -�Place�the�gear�wheel�(4-0238100)�into�the�lateral�opening�on�the�tibial�housing.

4 -�Press�the�blue�button�and�insert�the�femoral�housing�(4-0238000)�on�top�of�the�tibial�housing.

Disassembly of Balancer

•�Repeat�the�above�steps�in�the�reverse�order.

Disassembly of Pin Positioner

1 -�Unscrew�the�indexing�thumb�knob�(4-0248600).

2 -�Remove�the�dowel�(4-0248500).

3 -�Take�the�H2.5�wrench�(2-0228200).

4 -�Unscrew�the�pan-head�screw.

5 -�Remove�the�saw�blade�guide.

Assembly of Pin Positioner

•�Repeat�the�above�steps�in�the�reverse�order.

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Customer Service – France : Porte du Grand Lyon, 01700 Neyron – France Tel. : +33 (0)4 37 85 19 19 Fax : +33 (0)4 37 85 19 18

E-mail : [email protected]

Customer Service – Export : 11, cours Jacques Offenbach, Zone Mozart 2, 26000 Valence – France Tel. : +33 (0)4 75 41 87 41 Fax : +33 (0)4 75 41 87 42

Internet : www.amplitude-ortho.com