← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K960279 # NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES (K960279) _Zimmer, Inc. · JWH · Apr 26, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K960279 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Apr 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities. ## Device Story NexGen Legacy PS and CCK femoral components and articular surfaces; total knee replacement implants. Designed to reduce pain and restore knee joint function/motion. Used in orthopedic surgery; implanted by surgeons. Fixation achieved via bone cement. Components replace damaged joint surfaces in patients with severe arthritis or deformity. Benefits include pain relief and improved mobility. ## Clinical Evidence No clinical data provided. Substantial equivalence supported by literature studies on predicate devices demonstrating satisfactory clinical results. ## Technological Characteristics Metal/polymer semiconstrained cemented knee prosthesis. Components include femoral components and articular surfaces. Fixation via bone cement. ## 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 - NexGen Posterior Stabilized - Insall/Burstein II Posterior Stabilized - NexGen Constrained Condylar Knee - Insall/Burstein II Modular Knee System - Insall/Burstein Constrained Condylar Knee ## 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} PO. Box 708 Warsaw, IN 46581-0708 219 267-6131 K960279 # Summary of Safety and Effectiveness NexGen® Complete Knee Solution Legacy Posterior Stabilized (PS) and Constrained Condylar Knee (CCK) Femoral Components and Articular Surfaces ## Information is being submitted in accordance with the requirements of SMDA 1990 APR 26 1996 - Submitted by: Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 - Prepared by: Ruth Ann Wood Regulatory Affairs Associate - Date: January 18, 1996 - Trade Name: NexGen Legacy PS (L-PS) and NexGen Legacy CCK (L-CCK) - Classification Name: Knee joint femorotibial metal/polymer semiconstrained cemented prosthesis - Predicate Devices: - The NexGen Legacy Posterior Stabilized Knee equals NexGen Posterior Stabilized and Insall/Burstein II Posterior Stabilized - The NexGen Legacy Constrained Condylar Knee equals NexGen Constrained Condylar Knee, Insall/Burstein® II Modular Knee System, and Insall/Burstein® Constrained Condylar Knee 160 A Bristol-Myers Squibb Company {1} - Intended Use: To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities. - Comparison to Predicate Devices: See attached chart. - Clinical and Nonclinical Uses: Current methods of implant fixation rely on the use of bone cement. Numerous studies reported in literature indicate satisfactory results have been obtained through use of devices to which substantial equivalence is claimed. RA10501K.RP 161 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K960279](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K960279) **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