Product code KWZ
- Device name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3310
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P960054S003 | S-ROM POLY-DAIL CONSTRAINED LINER | Depuy, A Johnson & Johnson Co. | 1999-12-22 |
| P960054S002 | S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER | Depuy, A Johnson & Johnson Co. | 1999-12-07 |
| P960054S004 | S-ROM POLY-DIAL CONSTRAINED LINER | Depuy, A Johnson & Johnson Co. | 1999-11-10 |
| P960054 | S-ROM POLY-DIAL CONSTRAINED LINER | Depuy, A Johnson & Johnson Co. | 1997-06-19 |
| P960047 | OSTEONICS CONSTRAINED ACETABULAR INSERT | Howmedica Osteonics Corp. | 1997-06-13 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241461 | Mpact Constrained Liner | Medacta International S.A. | 2025-07-31 |
| K240639 | PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC | 2024-04-04 |
| K162641 | Smith & Nephew, Inc. R3™ Constrained Liner | Smith & Nephew, Inc. | 2017-06-19 |
| 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 |
| K161610 | EXPRT Revision Hip System | Encore Medical L.P. | 2016-11-09 |
| K122139 | SMITH & NEPHEW R3 CONSTRAINED LINERS | Smith & Nephew, Inc. | 2012-10-16 |
| K111635 | SMITH & NEPHEW RJ CONSTRAINED LINERS | Smith & Nephew, Inc. | 2011-09-09 |
| K101730 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS | Zimmer, Inc. | 2010-12-03 |
| K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER | Smith & Nephew, Inc. | 2009-03-03 |
| K072121 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | Zimmer, Inc. | 2008-01-07 |
| K071059 | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | DePuy Orthopaedics, Inc. | 2007-11-09 |
| K071676 | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS | Exactech, Inc. | 2007-07-19 |
| K071718 | TRILOGY LONGEVITY CONSTRAINED LINER | Zimmer, Inc. | 2007-07-13 |
| K071117 | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2007-05-18 |
| K063552 | SERIES II CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 |
| K063550 | SYSTEM 12 CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 |
| K063445 | PCA CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 |
| K061654 | TRIDENT CONSTRAINED ACETABULAR INSERT | Howmedica Osteonics Corp. | 2006-07-07 |
| K052079 | PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2005-10-21 |
| K043058 | PINNACLE CONSTRAINED ACETABULAR LINERS | Depuy, Inc. | 2005-03-14 |
| K040601 | EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS | Exactech, Inc. | 2004-10-04 |
| K040225 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | Osteoimplant Technology, Inc. | 2004-05-06 |
| K033442 | REFLECTION CONSTRAINED LINER | Smith & Nephew, Inc. | 2003-11-26 |
| K030923 | EPSILON DURASUL CONSTRAINED ACETABULAR LINER | Centerpulse Orthopedics, Inc. | 2003-10-03 |
| K023794 | CONSTRAINED LINER | Encore Medical L.P. | 2003-04-01 |
| K030047 | FREEDOM CONSTRAINED LINERS | Biomet, Inc. | 2003-01-23 |
| K021826 | TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES | Zimmer, Inc. | 2002-12-20 |
| K021803 | REFLECTION CONSTRAINED LINER | Smith & Nephew, Inc. | 2002-12-19 |
| K021728 | RINGLOC CONSTRAINED LINERS II | Biomet, Inc. | 2002-10-25 |
| K021661 | RINGLOC CONSTRAINED LINERS | Biomet Orthopedics, Inc. | 2002-10-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613153071587 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072942 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072935 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072928 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072911 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072904 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072898 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072881 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072874 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072867 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071655 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071648 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071617 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071600 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071594 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071273 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071440 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071433 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071426 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071419 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071402 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071396 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071389 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071372 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071365 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071341 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071334 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071327 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071310 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071297 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |