KWZ · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Orthopedic · 21 CFR 888.3310 · Class 2
Overview
| Product Code | KWZ |
|---|---|
| Device Name | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Regulation | 21 CFR 888.3310 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 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.”
Cleared Devices (36)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241461 | Mpact Constrained Liner | Medacta International S.A. | Jul 31, 2025 | SESE |
| K240639 | PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC | Apr 4, 2024 | SESE |
| K162641 | Smith & Nephew, Inc. R3 Constrained Liner | Smith & Nephew, Inc. | Jun 19, 2017 | SESE |
| K163497 | 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 | EXPRT Revision Hip System | Encore Medical L.P. | Nov 9, 2016 | SESE |
| K122139 | SMITH & NEPHEW R3 CONSTRAINED LINERS | Smith & Nephew, Inc. | Oct 16, 2012 | SESE |
| K111635 | SMITH & NEPHEW RJ CONSTRAINED LINERS | Smith & Nephew, Inc. | Sep 9, 2011 | SESE |
| K101730 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS | Zimmer, Inc. | Dec 3, 2010 | SESE |
| K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER | Smith & Nephew, Inc. | Mar 3, 2009 | SESE |
| K072121 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | Zimmer, Inc. | Jan 7, 2008 | SESE |
| K071059 | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | DePuy Orthopaedics, Inc. | Nov 9, 2007 | SESE |
| K071676 | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS | Exactech, Inc. | Jul 19, 2007 | SESE |
| K071718 | TRILOGY LONGEVITY CONSTRAINED LINER | Zimmer, Inc. | Jul 13, 2007 | SESE |
| K071117 | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | May 18, 2007 | SESE |
| K063552 | SERIES II CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | Mar 8, 2007 | SESE |
| K063550 | SYSTEM 12 CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | Mar 8, 2007 | SESE |
| K063445 | PCA CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | Mar 8, 2007 | SESE |
| K061654 | TRIDENT CONSTRAINED ACETABULAR INSERT | Howmedica Osteonics Corp. | Jul 7, 2006 | SESE |
| K052079 | PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | Oct 21, 2005 | SESE |
| K043058 | PINNACLE CONSTRAINED ACETABULAR LINERS | Depuy, Inc. | Mar 14, 2005 | SESE |
| K040601 | EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS | Exactech, Inc. | Oct 4, 2004 | SESE |
| K040225 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | Osteoimplant Technology, Inc. | May 6, 2004 | SESE |
| K033442 | REFLECTION CONSTRAINED LINER | Smith & Nephew, Inc. | Nov 26, 2003 | SESE |
| K030923 | EPSILON DURASUL CONSTRAINED ACETABULAR LINER | Centerpulse Orthopedics, Inc. | Oct 3, 2003 | SESE |
| K023794 | CONSTRAINED LINER | Encore Medical L.P. | Apr 1, 2003 | SESE |
| K030047 | FREEDOM CONSTRAINED LINERS | Biomet, Inc. | Jan 23, 2003 | SESE |
| K021826 | TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES | Zimmer, Inc. | Dec 20, 2002 | SESE |
| K021803 | REFLECTION CONSTRAINED LINER | Smith & Nephew, Inc. | Dec 19, 2002 | SESE |
| K021728 | RINGLOC CONSTRAINED LINERS II | Biomet, Inc. | Oct 25, 2002 | SESE |
| K021661 | RINGLOC CONSTRAINED LINERS | Biomet Orthopedics, Inc. | Oct 25, 2002 | SESE |
| P960054 | S-ROM POLY-DIAL CONSTRAINED LINER | Depuy, A Johnson & Johnson Co. | Jun 19, 1997 | APRL |
| P960047 | OSTEONICS CONSTRAINED ACETABULAR INSERT | Howmedica Osteonics Corp. | Jun 13, 1997 | APRL |
| K950202 | RINGLOC CONSTRAINED LINER | Biomet, Inc. | May 15, 1995 | SESE |
| K890197 | OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT | Osteonics Corp. | Apr 7, 1989 | SESE |
| K870271 | S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP | Joint Medical Products Corp. | Apr 20, 1987 | SN |
| K803192 | HCL ACETABULAR COMPONENTS | Osteonics Corp. | Jan 23, 1981 | 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
