Overview; Indication For Use; Training; Implant Indications - Zimmer Biomet iASSIST Knee Manual

iASSIST 2-Pod Version Surgical Technique
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Overview

Indication for Use

The iASSIST Knee System is a computer assisted
stereotaxic surgical instrument system to assist the
surgeon in the positioning of orthopedic implant
system components intraoperatively. It involves
surgical instruments and position sensors to determine
axial alignment in relation to anatomical landmarks to
help precisely position alignment instruments and
implant components relative to these axes.
The present iASSIST Knee System is designed for total
knee arthroplasty.

Training

Prior to using the system, surgeons should follow a
training given by Zimmer CAS or the distributor for the
given applications. Contact your local Zimmer Biomet
representative.
Warning: The system should only be used by
trained surgeons.

Implant Indications

The prosthesis implanted with the system must be
used in accordance with the appropriate package
insert labeling.
The procedure is to be performed in accordance with
the corresponding surgical technique published by
the manufacturer for the specific implant.
Warning: The system should only be used with the
instruments provided by Zimmer CAS or by the
distributor for the given application.

Contraindications

Clinical
The system should not be used:
• In cases of hip pathology severely limiting range
of motion (e.g. arthrodesis, severe contractures,
chronic severe dislocation);
• In cases of hip joint pathology or knee pathology
with significant bone loss (e.g. avascular necrosis
of the femoral head with collapse, severe dysplasia
of the femoral head or the acetabulum, femoral
condyle collapse);
• For femoral anterior cut first surgical techniques;
• For total knee arthroplasty using the
Quad-Sparing™ technique; or
• For any other contraindicated case, as given
by the implant manufacturer.
General
The system should not be used:
• On a moving vehicle, or any mobile platform; or
• To perform surgical procedures other than those
specified in the surgical technique defined in this
document.

Complications

Possible complications associated with the use of
the system may include but are not limited to the
following:
• Infection; and
• Misplacement of the implants potentially
leading to dislocation, impingement or
leg length discrepancy.
The occurrence of one of these complications may
affect the patient's mobility.