← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K963148 # NEXGEN COMPLETE KNEE SOLUTION (K963148) _Zimmer, Inc. · JWH · Feb 13, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K963148 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Feb 13, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## 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. ## Device Story NexGen® Complete Knee Solution Fluted Stemmed Tibial Component; forged Tivanium® Ti-6Al-4V alloy; implanted during total knee arthroplasty; cement-only fixation. Device features fluted stem base design to direct cement flow from distal tip to proximal surface, enhancing fixation. Mates with NexGen Knee CR, CRA, PS, L-PS, and L-CCK articular surfaces. Used by orthopedic surgeons in clinical settings to replace damaged knee joint surfaces; provides structural support and stability for knee joint; improves patient mobility. ## Clinical Evidence Bench testing only; fatigue strength data submitted. ## Technological Characteristics Material: Forged Tivanium® Ti-6Al-4V alloy. Design: Fluted stemmed tibial component with cement mantle pockets. Fixation: Cement-only. Connectivity: None. Software: None. ## 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® Complete Knee Solution - Insall/Burstein® Total 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} P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131 zimmer K963148 Summary of Safety and Effectiveness FEB 13 1997 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, Indiana 46581-0708 - Prepared by: Ruth Ann Wood Senior Regulatory Affairs Associate - Date: August 12, 1996 - Trade Name: NexGen® Complete Knee Solution Fluted Stemmed Tibial Component - Classification: Class II 21 CFR 888.3530 - Predicate Devices: NexGen® Complete Knee Solution and the Insall/Burstein® Total Knee System - Device Description: The proposed fluted, stemmed tibials are made of forged Tivanium® Ti-6Al-4V Alloy. Like the tibials, NexGen® Complete Knee Solution, the fluted stemmed tibials cover a multitude of patient specific needs by mating with the NexGen Knee 52 A Bristol-Myers Squibb Company {1} CR, CRA, PS, L-PS and L-CCK articular surfaces. The proposed fluted stemmed tibial component shares many features with the NexGen Knee stemmed tibials discussed above. It is the same in these respects: - Length of the stem - Angle of the stem relative to the distal plate surface - Position of the cylindrical portion of the stem in the anterior/posterior direction - Stem extension locking taper design - Articular surface locking mechanism - Minimum taper wall thickness - Depth of the cement mantle pockets in the distal plate surface, size offerings, and material. The primary difference between the proposed fluted stemmed tibial components and the cleared stemmed tibial component involves the stem base shape. The proposed design uses flutes like the Insall/Burstein® Knee predicate design. The stem base shape has a posterior slope similar to the Insall/Burstein Knee. The stem base has a flute on both the lateral and medial edges which provide channels to direct cement flow from the distal tip to the proximal surface of the cut tibial during insertion, thus, enhancing cement fixation. These flutes give the implant its name. The cleared stemmed tibial component ribs have been replaced by integral flared supports at the base of the stem. - 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 was submitted in the 510(k) for fatigue strength. RA07601K.510 *Insall/Burstein trademark of The Hospital for Special Surgery 2 53 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K963148](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K963148) **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. 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