(78 days)
Knee femoral components are single use devices implanted in the human knee during total knee arthroplasty. This knee is intended for cement use only.
The femorals are made of cast Zimaloy® Cobalt-Chromium-Molybdenum Alloy. They are hardened by the Co-Nidium™ Surface Hardening Process described in Section XI. They are available in left and right configurations. NexGen/Legacy Knee femorals cover a multitude of patient specific needs with the Cruciate Retaining (CR), Posterior Stabilizing (PS and L-PS), Cruciate Retaining Augmentable (CRA), and Constrained Condylar Knee (L-CCK) designs. Certain femorals can be augmented with stem extensions. The extensions come in a broad variety of straight and offset shapes as well as numerous lengths and diameters. These femorals will be available in precoat, porous, and option (NoCoat) versions.
This document is a Summary of Safety and Effectiveness for medical devices (NexGen® Complete Knee Solution and Legacy™ Knee System with Co-Nidium™ Surface Hardening Process). It describes the devices and their intended use but does not contain information related to acceptance criteria or the study data proving the device meets those criteria, as typically requested for AI/ML device evaluations.
Specifically, the document states: "The performance data submitted in the 510(k) demonstrated the improved wear resistance compared to nontreated femoral components." However, it does not provide the acceptance criteria, the specific study design, sample sizes, ground truth methodology, or expert qualifications that would be necessary to answer the questions posed.
Therefore, I cannot extract the requested information from the provided text.
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P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
62196
Summary of Safety and Effectiveness
The summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990.
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Submitted by:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 -
. Prepared by:
Ruth Ann Wood Senior Regulatory Affairs Associate -
Date: .
June 5, 1996 -
Trade Name: .
NexGen® Complete Knee Solution with Co-Nidium™ Surface Hardening Process and Legacy™ Knee System with Co-Nidium™ Surface Hardening Process -
Classification: .
Class II 21 CFR 888.3530 -
. Predicate Devices:
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Cobalt-Chromium Molybdenum Alloy Femoral Heads with Co-Nidium Surface Hardening Process; MG II® Total Knee System with Ti-Nidium® Surface Hardening Process; MG II® Porous Total Knee System, NexGen® Complete Knee Solution; and the Legacy™ Knee System Device Description:
The femorals are made of cast Zimaloy® Cobalt-Chromium-Molybdenum Alloy. They are hardened by the Co-Nidium™ Surface Hardening Process described in
Image /page/0/Picture/18 description: The image contains the number 1. The number is black and is set against a white background. The number is tall and thin.
Image /page/0/Picture/19 description: The image shows a logo with a geometric design on the left and the text "A Bristol-Myers" on the right. The geometric design is a hexagon composed of six smaller triangles, each containing an even smaller triangle inside. The text is in a simple, sans-serif font and is aligned horizontally with the geometric design.
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They are hardened by the Co-Nidium™ Surface Hardening Process described in Section XI. They are available in left and right configurations. NexGen/Legacy Knee femorals cover a multitude of patient specific needs with the Cruciate Retaining (CR), Posterior Stabilizing (PS and L-PS), Cruciate Retaining Augmentable (CRA), and Constrained Condylar Knee (L-CCK) designs. Certain femorals can be augmented with stem extensions. The extensions come in a broad variety of straight and offset shapes as well as numerous lengths and diameters. These femorals will be available in precoat, porous, and option (NoCoat) versions.
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Intended Use:
Knee femoral components are single use devices implanted in the human knee during total knee arthroplasty. This knee is intended for cement use only. -
Performance Data: .
The performance data submitted in the 510(k) demonstrated the improved wear resistance compared to nontreated femoral components.
RA05603K.510
N/A