FDA Product Code
FDA Product Code KWZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3310
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241461 | Mpact Constrained Liner | Medacta International S.A. | 2025-07-31 | Traditional | PDF ↗ |
| K240639 | PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC | 2024-04-04 | Special | PDF ↗ |
| K162641 | Smith & Nephew, Inc. R3 Constrained Liner | Smith & Nephew, Inc. | 2017-06-19 | Traditional | PDF ↗ |
| 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. | 2017-03-02 | Traditional | PDF ↗ |
| K161610 | EXPRT Revision Hip System | Encore Medical L.P. | 2016-11-09 | Traditional | PDF ↗ |
| K122139 | SMITH & NEPHEW R3 CONSTRAINED LINERS | Smith & Nephew, Inc. | 2012-10-16 | Traditional | PDF ↗ |
| K111635 | SMITH & NEPHEW RJ CONSTRAINED LINERS | Smith & Nephew, Inc. | 2011-09-09 | Traditional | PDF ↗ |
| K101730 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS | Zimmer, Inc. | 2010-12-03 | Traditional | PDF ↗ |
| K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER | Smith & Nephew, Inc. | 2009-03-03 | Traditional | PDF ↗ |
| K072121 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | Zimmer, Inc. | 2008-01-07 | Traditional | PDF ↗ |
| K071059 | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | DePuy Orthopaedics, Inc. | 2007-11-09 | Traditional | PDF ↗ |
| K071676 | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS | Exactech, Inc. | 2007-07-19 | Special | PDF ↗ |
| K071718 | TRILOGY LONGEVITY CONSTRAINED LINER | Zimmer, Inc. | 2007-07-13 | Traditional | PDF ↗ |
| K071117 | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2007-05-18 | Special | PDF ↗ |
| K063552 | SERIES II CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 | Traditional | PDF ↗ |
| K063445 | PCA CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 | Traditional | PDF ↗ |
| K063550 | SYSTEM 12 CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 | Traditional | PDF ↗ |
| K061654 | TRIDENT CONSTRAINED ACETABULAR INSERT | Howmedica Osteonics Corp. | 2006-07-07 | Special | PDF ↗ |
| K052079 | PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2005-10-21 | Traditional | PDF ↗ |
| K043058 | PINNACLE CONSTRAINED ACETABULAR LINERS | Depuy, Inc. | 2005-03-14 | Traditional | PDF ↗ |
| K040601 | EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS | Exactech, Inc. | 2004-10-04 | Abbreviated | PDF ↗ |
| K040225 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | Osteoimplant Technology, Inc. | 2004-05-06 | Traditional | PDF ↗ |
| K033442 | REFLECTION CONSTRAINED LINER | Smith & Nephew, Inc. | 2003-11-26 | Special | PDF ↗ |
| K030923 | EPSILON DURASUL CONSTRAINED ACETABULAR LINER | Centerpulse Orthopedics, Inc. | 2003-10-03 | Traditional | PDF ↗ |
| K023794 | CONSTRAINED LINER | Encore Medical L.P. | 2003-04-01 | Abbreviated | PDF ↗ |
| K030047 | FREEDOM CONSTRAINED LINERS | Biomet, Inc. | 2003-01-23 | Special | PDF ↗ |
| K021826 | TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES | Zimmer, Inc. | 2002-12-20 | Traditional | PDF ↗ |
| K021803 | REFLECTION CONSTRAINED LINER | Smith & Nephew, Inc. | 2002-12-19 | Abbreviated | PDF ↗ |
| K021661 | RINGLOC CONSTRAINED LINERS | Biomet Orthopedics, Inc. | 2002-10-25 | Traditional | PDF ↗ |
| K021728 | RINGLOC CONSTRAINED LINERS II | Biomet, Inc. | 2002-10-25 | Traditional | PDF ↗ |
| K950202 | RINGLOC CONSTRAINED LINER | Biomet, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K890197 | OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT | Osteonics Corp. | 1989-04-07 | Traditional | PDF ↗ |
| K870271 | S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP | Joint Medical Products Corp. | 1987-04-20 | Traditional | PDF ↗ |
| K803192 | HCL ACETABULAR COMPONENTS | Osteonics Corp. | 1981-01-23 | Traditional | PDF ↗ |
Product code KWZ · Class II · Orthopedic. Data: openFDA.