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General Total Knee Arthroplasty (TKR) Indications:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

· Post-traumatic loss of knee joint configuration and function.

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Revision of previous unsuccessful knee replacement or other procedure.

· Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques.

The Triathlon Tritanium Tibial Baseplate and Tritanium Metal-Backed Patella components are indicated for both uncemented and cemented use.

The Triathlon Total Knee System beaded with Peri-Apatite components are intended for uncemented use only.

The Triathlon All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) Components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
• · Severe anteroposterior instability of the knee joint.

This submission covers Mako Total Knee Application-compatible components of the Triathlon® Total Knee System intended for use with the Mako System during a total knee arthroplasty. These include cruciate-retaining (CR), condylar stabilized (CS) and posterior stabilized (PS) components, tibial baseplates and TS tibial inserts. Triathlon® Total Knee System PSR tibial inserts are being reviewed for compatibility with the Mako Total Knee Application under K193515. The Triathlon® Total Knee System components have been previously cleared in prior 510(k) submissions and are commercially available. The Mako Total Knee Application-compatible Triathlon® Total Knee System components are manufactured from the following materials: Cobalt Chromium Alloy, Titanium Alloy, Commercially Pure Titanium, Ultra-High Molecular Weight Polyethylene and Calcium Phosphate.

This FDA 510(k) summary for the Triathlon® Total Knee System (K201343) does not describe a study involving an AI/CADe device and therefore does not include the requested information about acceptance criteria or a study proving device performance against such criteria in the context of AI.

The submission is for the addition of an individualized alignment preoperative planning methodology for the Triathlon® Total Knee System components used in conjunction with the Mako System during total knee arthroplasty. The Mako System itself (a robotic arm assisted surgery system) is not the subject of this 510(k), but rather the specific set of knee replacement components compatible with its planning application.

The document indicates that:

• The Triathlon® Total Knee System components have been previously cleared.
• This submission focuses on compatibility and an individualized alignment preoperative planning method for these components.
• Non-clinical laboratory assessments were previously performed on the components.
• Clinical testing was not required as a basis for substantial equivalence for this specific submission.

Therefore, I cannot provide the requested information. The document explicitly states "Clinical testing is not required as a basis for substantial equivalence," meaning no new clinical study was conducted for this specific submission to demonstrate performance against acceptance criteria for an AI or CADe device.

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