Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3310](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3310) → KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer # KWZ · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer _Orthopedic · 21 CFR 888.3310 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ ## Overview - **Product Code:** KWZ - **Device Name:** Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer - **Regulation:** [21 CFR 888.3310](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3310) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027). ## Classification Rationale Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.” ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.” ## Recent Cleared Devices (20 of 36) Showing 20 most recent of 36 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241461](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K241461.md) | Mpact Constrained Liner | Medacta International S.A. | Jul 31, 2025 | SESE | | [K240639](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K240639.md) | PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC | Apr 4, 2024 | SESE | | [K162641](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K162641.md) | Smith & Nephew, Inc. R3™ Constrained Liner | Smith & Nephew, Inc. | Jun 19, 2017 | SESE | | [K163497](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K163497.md) | EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt | Encore Medical L.P. | Mar 2, 2017 | SESE | | [K161610](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K161610.md) | EXPRT Revision Hip System | Encore Medical L.P. | Nov 9, 2016 | SESE | | [K122139](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K122139.md) | SMITH & NEPHEW R3 CONSTRAINED LINERS | Smith & Nephew, Inc. | Oct 16, 2012 | SESE | | [K111635](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K111635.md) | SMITH & NEPHEW RJ CONSTRAINED LINERS | Smith & Nephew, Inc. | Sep 9, 2011 | SESE | | [K101730](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K101730.md) | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS | Zimmer, Inc. | Dec 3, 2010 | SESE | | [K083566](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K083566.md) | R3 CONSTRAINED LINER, CONSTRAINED LINER | Smith & Nephew, Inc. | Mar 3, 2009 | SESE | | [K072121](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K072121.md) | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | Zimmer, Inc. | Jan 7, 2008 | SESE | | [K071059](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K071059.md) | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | DePuy Orthopaedics, Inc. | Nov 9, 2007 | SESE | | [K071676](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K071676.md) | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS | Exactech, Inc. | Jul 19, 2007 | SESE | | [K071718](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K071718.md) | TRILOGY LONGEVITY CONSTRAINED LINER | Zimmer, Inc. | Jul 13, 2007 | SESE | | [K071117](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K071117.md) | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | May 18, 2007 | SESE | | [K063552](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K063552.md) | SERIES II CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | Mar 8, 2007 | SESE | | [K063550](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K063550.md) | SYSTEM 12 CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | Mar 8, 2007 | SESE | | [K063445](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K063445.md) | PCA CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | Mar 8, 2007 | SESE | | [K061654](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K061654.md) | TRIDENT CONSTRAINED ACETABULAR INSERT | Howmedica Osteonics Corp. | Jul 7, 2006 | SESE | | [K052079](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K052079.md) | PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | Oct 21, 2005 | SESE | | [K043058](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ/K043058.md) | PINNACLE CONSTRAINED ACETABULAR LINERS | Depuy, Inc. | Mar 14, 2005 | SESE | ## Top Applicants - Smith & Nephew, Inc. — 6 clearances - Howmedica Osteonics Corp. — 5 clearances - Zimmer, Inc. — 4 clearances - Encore Medical L.P. — 3 clearances - DePuy Orthopaedics, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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