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21 | iASSIST 2-Pod Version Surgical Technique

3.4.4 Distal Femoral Cut Validation (cont)

Note: To restart the distal femur cut validation,

press the “Z” button on the Pod attached to the

Validation Tool or the “Restart” button on the

bottom right of the iASSIST Tablet Screen.

8. A drop rod can optionally be inserted in the handle

of the Validation Tool to check the varus/valgus

orientation of the cut. Make sure that the arm of

the Validation Tool is aligned with the A/P plane of

the femur.

Warning: The Femoral Distal Cut Guide must

not have moved in reference to the bone to

perform an accurate distal cut validation.

When setting femoral rotation after the cut is

validated, pay attention not to use the holes

created by the validation tool as they may

have the same distance between pegs as other

femoral rotational setting instruments

Figure 3.4.4

Distal Femur Cut – Validation (cont)

9. If two 3.5 x 38 mm Hex Head Screw were used,

remove those screws. Remove the Validation Tool

by lifting the tool o of the bone by hand, straight

away from the cut plane.

10. Remove the 3.2 mm Headless Trocar Drill Pins,

the Femoral Saw Slot, and the Femoral Distal Cut

Guide.

Note: If the femur cut needs to be corrected,

it is possible to navigate the orientation of the

Cut Guide in order to execute the cut again. To

do so: 1. Remove the “Reference” Pod attached

to the Validation Tool and clip it to the Femoral

Reference. 2. Press the “Quit” button, then

the “Workow” button and then “Conrm”. 3.

Proceed with Femoral Workow Selection and

Registration.

11. Proceed with the tibia registration if continuing

with the proximal tibia cut. Refer to the Workow

Selection section for more details.

Summary of content (15 pages)

PAGE 1
21 | iASSIST 2-Pod Version Surgical Technique Figure 3.4.4 Distal Femur Cut – Validation (cont) 3.4.4 Distal Femoral Cut Validation (cont) Note: To restart the distal femur cut validation, press the“Z”button on the Pod attached to the Validation Tool or the “Restart” button on the bottom right of the iASSIST Tablet Screen. 8. A drop rod can optionally be inserted in the handle of the Validation Tool to check the varus/valgus orientation of the cut.
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2 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.1 Tibia Workflow Selection 3.5 Tibia Procedure Warning: At patient draping, take care to leave the malleoli accessible to the surgeon. The iASSIST Knee system is compatible with Femur first and Tibia first procedure. See the “Femur Procedure” section to start with the femur. Note: There are three different techniques for tibia resection. The first one is the Freehand Positioning of the Tibial Adjustment Mechanism and will be described here.
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23 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.1 Tibia Workflow Selection (cont) 3.5.1 Workflow Selection for Tibia (cont) 4. Use three 3.5 x 38 mm Hex Head Screw to secure the Tibial Adjustment Mechanism to the bone by securing a screw in the (1) medial hole, (2) upper lateral hole, (3) lower lateral hole. Warning: From registration to validation, the instruments must remain stable and properly secured to the bone to ensure accuracy of the system.
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24 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.1 Tibia Workflow Selection (cont) 3.5.1 Workflow Selection for Tibia (cont) 7. Install the distal part of the Tibial Alignment Guide on the ankle by firmly gripping the distal clamps around the malleoli. Note: The Tibial Alignment Guide is designed to be self-centered when placed around the malleoli.
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25 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.1 Tibia Workflow Selection (cont) 3.5.1 Workflow Selection for Tibia (cont) Warning: Do not pull on the distal part of the Tibial Alignment Guide once both spikes have been inserted into the tibia. Doing so may result in bending of the spikes. 10. While continuing to firmly grip the distal clamps around the malleoli, impact the instrument until both spikes are fully inserted in the tibia. 11.
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26 | iASSIST 2-Pod Version Surgical Technique Abduction Adduction Neutral Figure 3.5.2 Proximal Tibia Cut – Tibial Registration 3.5.2 Tibial Registration 1. Ensure the “Cut Guide” Pod is clipped to the Tibial Alignment Guide. 2. Press the “Z” button on the Pod attached to the Tibial Alignment Guide to initiate the registration procedure. For steps 3-5, follow the feedback on the Pod attached to the Tibial Alignment Guide. The iASSIST V2 Tablet will also provide audio and visual feedback.
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27 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.2 Proximal Tibia Cut – Tibial Registration 3.5.2 Tibial Registration (cont) Note: To restart the tibial registration, press the “Z” button on the Pod attached to the Tibial Aligment Guide or the “Restart” button on the bottom right of the iASSIST V2 Tablet Screen. 6. Loosen the blue knob on the distal end of theTibial Alignment Guide 7. Unspike the proximal part of the Tibial Alignment Guide from the tibia using a slaphammer.
PAGE 8
28 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.3 Proximal Tibial Cut 3.5.3 Proximal Tibial Cut Guidance 1. Unclip the “Cut Guide” Pod from the Tibial Alignment Guide and clip it to the front receptable of the Tibial Adjustment Mechanism. 2. Follow feedback (red and green LEDs) on the “Cut Guide” Pod attached to the Tibial Adjustment Mechanism and adjust tibia slope and varus/ valgus using the gold and green screws respectively. 3. Insert a stylus in the Tibial Cut Guide.
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29 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.3 Proximal Tibial Cut (cont) 3.5.3 Proximal Tibial Cut Guidance (cont) Note: Each line increment on the elevator rod measures 2 mm. 5. Set the resection level in accordance with the standard surgical technique. 6. Ensure that the Tibial Cut Guide is well seated on the anterior contour of the tibia (i.e. medial side of the Tibial Cut Guide must be in contact with the tibia). 7.
PAGE 10
30 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.3 Proximal Tibial Cut (cont) 3.5.3 Proximal Tibial Cut Guidance (cont) Warning: If the Tibial Adjustment Mechanism is not fixed securely or moves, the tibia registration should be performed again. Repeat the steps described in the “Tibia Registration” section. 11. A drop rod can optionally be used to check the varus/valgus orientation of the cut before performing the resection. Insert the paddle section of the Alignment Arch in the Tibial Cut Guide.
PAGE 11
31 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.4 Proximal Tibial Cut – Validation 3.5.4 Proximal Tibial Cut Validation 1. Remove the “Cut Guide” Pod attached to the front receptacle of the Tibial Adjustment Mechanism and clip it to the Validation Tool. 2. Position the flat surface of the Validation Tool on the proximal tibia cut. 3. Secure the Validation Tool on the proximal tibia cut by gently impacting the captive spikes. Additionally, two 3.
PAGE 12
32 | iASSIST 2-Pod Version Surgical Technique Abduction Adduction Neutral Figure 3.5.4 Proximal Tibial Cut – Validation 3.5.3 Proximal Tibial Cut Guidance (cont) For steps 4-6, make sure to hold the Validation Tool in place with one hand while performing the validation steps and follow the feedback on the Pod attached to the Validation Tool. The iASSIST V2 Tablet will also provide audio and visual feedback.
PAGE 13
33 | iASSIST 2-Pod Version Surgical Technique Figure 3.5.4 Proximal Tibial Cut – Validation 3.5.3 Proximal Tibial Cut Guidance (cont) Warning: Ensure to hold the Tibial Adjustment Mechanism while removing the 3.5 x 38 mm Hex Head Screws from it. Make sure to remove those screws in the angular orientation of the initial hole. Removing the last scew that was put in first (first screw in, last screw out) can help to keep the right orientation.
PAGE 14
34 | iASSIST 2-Pod Version Surgical Technique Figure 3.6.1 Tibial Positioner Technique- Instrument Assembly 3.6 Alternate Techniques to Prepare Tibia Cut The following section describes two alternate techniques for positioning the Tibial Adjustment Mechanism on the tibia. 3.6.1 Tibial Positioner Technique Instrument assembly Note: The Tibial Positioners are side specific and must be used with the corresponding Tibial Adjustment Mechanism.
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35 | iASSIST 2-Pod Version Surgical Technique Figure 3.6.1 Tibial Positioner Technique- Workflow Selection 3.6.1 Tibial Positioner Technique (cont) 3. Install the distal part of the Tibial Alignment Guide on the ankle by firmly gripping the distal clamps around the malleoli. 6. While continuing to firmly grip the distal clamps around the malleoli, impact the instrument until both spikes are fully inserted in the tibia.