← Product Code [JWH](/productcode/JWH) · K962196 # NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS (K962196) _Zimmer, Inc. · JWH · Aug 23, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K962196 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [JWH](/productcode/JWH.md) - **Decision Date:** Aug 23, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for 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. ## Device Story NexGen and Legacy knee femoral components; cast Zimaloy (Co-Cr-Mo alloy) construction; Co-Nidium surface hardening process for improved wear resistance. Available in left/right configurations; designs include Cruciate Retaining (CR), Posterior Stabilizing (PS, L-PS), Cruciate Retaining Augmentable (CRA), and Constrained Condylar Knee (L-CCK). Options include stem extensions (straight/offset, various lengths/diameters) and surface finishes (precoat, porous, NoCoat). Implanted by orthopedic surgeons during total knee arthroplasty; intended for cemented fixation to restore joint function and reduce wear. ## Clinical Evidence Bench testing only; performance data demonstrated improved wear resistance of Co-Nidium surface-hardened femoral components compared to non-treated femoral components. ## Technological Characteristics Material: Cast Zimaloy (Cobalt-Chromium-Molybdenum alloy). Surface treatment: Co-Nidium surface hardening process. Design: Femoral components with various configurations (CR, PS, L-PS, CRA, L-CCK) and stem extension options. Fixation: Cemented only. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - 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 - Legacy™ Knee System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Zimmer AUG 23 1996 P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131 K962196 # Summary of Safety and Effectiveness The summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990. - 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: 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 73 A Bristol-Myers Squibb Company {1} 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. - 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 74 --- **Source:** [https://fda-staging.innolitics.com/device/K962196](https://fda-staging.innolitics.com/device/K962196) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com