← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K955884 # COORDINATE REVISION KNEE SYSTEM (K955884) _Depuy, Inc. · JWH · Mar 13, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K955884 ## Device Facts - **Applicant:** Depuy, Inc. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Mar 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The DePuy Coordinate II Revision Knee System is indicated for use with bone cement as either a primary or revision tricompartmental knee replacement system. ## Device Story Tricompartmental knee prosthesis; modification of Coordinate Revision Knee System. Design changes: threaded stem extensions for femoral/tibial components; modified central posts to accept threaded stems; cast Co-Cr-Mo tibial trays; increased conformity of tibial insert articular surfaces. Used in orthopedic surgery for total knee arthroplasty; implanted by surgeons. Provides structural replacement for knee joint; restores joint function; benefits patients via improved stability and fixation compared to previous tapered designs. ## Clinical Evidence Bench testing only. ## Technological Characteristics Materials: Cast Co-Cr-Mo (tibial trays). Design: Semi-constrained, cemented, tricompartmental knee prosthesis. Features: Threaded stem extensions for femoral and tibial components; modified central posts; conforming tibial inserts. Classification: 888.3560. ## 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 - DePuy AMK Landmark Revision Knee System and Full Wedge Tibial Tray (renamed the Coordinate Revision Knee System) - Johnson & Johnson P.F.C. Modular Knee System - DePuy Synatomic Variable Fit Tibial Plateau - DePuy AMK Congruency PS Tibial Inserts ## 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} K955884 # SUMMARY OF SAFETY AND EFFECTIVENESS | **NAME OF FIRM:** | DePuy Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 | | --- | --- | | **510(k) CONTACT:** | Cheryl Hastings Manager, Pre-clinical Device Evaluation | | **TRADE NAME:** | DePuy Coordinate II Revision Knee System | | **COMMON NAME:** | Knee Prosthesis | | **CLASSIFICATION:** | 888.3560 - Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | | **DEVICE PRODUCT CODE:** | 87 JWH | | **SUBSTANTIALLY EQUIVALENT DEVICES:** | - DePuy AMK Landmark Revision Knee System and Full Wedge Tibial Tray (renamed the Coordinate Revision Knee System) - Johnson & Johnson P.F.C. Modular Knee System - DePuy Synatomic Variable Fit Tibial Plateau - DePuy AMK Congruency PS Tibial Inserts | ## INTENDED USE AND DEVICE DESCRIPTION: The Coordinate II Revision Knee System is a design modification of the Coordinate Revision Knee System which was previously cleared by FDA for cemented use. The design modifications consist of the following: stem extensions for femoral and tibial components will be threaded rather than tapered; central posts on the femoral components and tibial trays will be modified to accept the threaded stem extensions; all tibial trays will be manufactured from cast Co-Cr-Mo; and the articular surface of the tibial inserts will be modified to be slightly more conforming. The DePuy Coordinate II Revision Knee System is indicated for use with bone cement as either a primary or revision tricompartmental knee replacement system. ## BASIS OF SUBSTANTIAL EQUIVALENCE: The Coordinate II Revision Knee System is similar to the Coordinate Revision Knee System previously cleared by FDA with the exception of the design change listed under DEVICE DESCRIPTION. The material, manufacturing process, intended use (cemented total knee arthroplasty) and the basic design of the Coordinate II Revision Knee System, including sizes of femoral components, tibial trays, and tibial inserts will not be changed from those of the Coordinate Revision Knee System previously cleared by FDA. 000016 105 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K955884](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K955884) **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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