Search Results

This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also indicated for the revision of knee prosthesis. The HLS NOETOS Revision prosthesis is intended for cemented use only.

The HLS NOETOS System is intended for use as a total knee replacement system sacrificing the cruciate ligaments. The HLS NOETOS System provides the flexibility needed to adapt the implant and the therapeutic solution to the patients need. All the type of implants have been designed with the same objectives: to restore the joint line both in flexion and in extension without altering the patellar height, to restore the articular morphology and to preserve bone stock. The design of the implant, particularly the tibial one, guarantees the antero-posterior stability, by a third femoral condyle that engages a specific tibial bearing area during flexion. The HLS NOETOS System - Revision prosthesis consists of the association of three components: a femoral component, a tibial tray associated with a polyethylene bearing and a patellar implant. The patella can be preserved if it is in good state or resurfaced by the patellar implant. Femoral and tibial augments as well as femoral and tibial extension stems can be added in order to compensate for bone loss.

This is a 510(k) premarket notification for a medical device (HLS NOETOS System - Revision prosthesis), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance (such as sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable or available in the provided document.

The document describes a traditional medical device (knee joint prosthesis) and its substantial equivalence to predicate devices, which is a regulatory pathway that does not involve the type of performance evaluation typically conducted for AI/ML software.

The provided text focuses on:

• Device Name: HLS NOETOS System - Revision prosthesis
• Submitter: Tornier S.A.
• Classification: Class II medical device (Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis)
• Predicate Devices: PFC Modular Total Knee System (DePuy), NEX-GEN Complete Knee Solution Legacy Constrained Condylar Knee L-CCK (Zimmer), HLS Noetos System (Tornier).
• Device Description: A total knee replacement system consisting of a femoral component, a tibial tray with a polyethylene bearing, and an optional patellar implant, designed to restore joint line, articular morphology, and preserve bone stock.
• Materials: Cobalt-Chromium alloy for femoral part, tibial tray, spacers, stem adaptors, and sleeve.
• Indications for Use: Total knee replacement for relief of pain and disability due to primary/secondary osteoarthritis and rheumatoid arthritis, and revision of knee prosthesis. Intended for cemented use only.
• FDA Decision: Substantial equivalence determination to legally marketed predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information in the format specified, as it pertains to AI/ML device evaluation, which is not relevant to this document.

Ask a specific question about this device