KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class II
FDA product code KWZ covers "Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3310. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KWZ
- Device Class
- Class II
- Regulation Number
- 888.3310
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241461 | medacta international | Mpact Constrained Liner | July 31, 2025 |
| K240639 | depuy ireland uc | PINNACLETM Constrained Acetabular Liners | April 4, 2024 |
| K162641 | smith and nephew | Smith & Nephew, Inc. R3 Constrained Liner | June 19, 2017 |
| K163497 | encore medical l.p | EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset | March 2, 2017 |
| K161610 | encore medical l.p | EXPRT Revision Hip System | November 9, 2016 |
| K122139 | smith and nephew | SMITH & NEPHEW R3 CONSTRAINED LINERS | October 16, 2012 |
| K111635 | smith and nephew | SMITH & NEPHEW RJ CONSTRAINED LINERS | September 9, 2011 |
| K101730 | zimmer | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS | December 3, 2010 |
| K083566 | smith and nephew | R3 CONSTRAINED LINER, CONSTRAINED LINER | March 3, 2009 |
| K072121 | zimmer | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | January 7, 2008 |
| K071059 | depuy orthopaedics | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | November 9, 2007 |
| K071676 | exactech | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS | July 19, 2007 |
| K071718 | zimmer | TRILOGY LONGEVITY CONSTRAINED LINER | July 13, 2007 |
| K071117 | depuy orthopaedics | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | May 18, 2007 |
| K063552 | howmedica osteonics | SERIES II CONSTRAINED ACETABULAR LINERS | March 8, 2007 |
| K063445 | howmedica osteonics | PCA CONSTRAINED ACETABULAR LINERS | March 8, 2007 |
| K063550 | howmedica osteonics | SYSTEM 12 CONSTRAINED ACETABULAR LINERS | March 8, 2007 |
| K061654 | howmedica osteonics | TRIDENT CONSTRAINED ACETABULAR INSERT | July 7, 2006 |
| K052079 | depuy orthopaedics | PINNACLE CONSTRAINED ACETABULAR LINERS | October 21, 2005 |
| K043058 | depuy | PINNACLE CONSTRAINED ACETABULAR LINERS | March 14, 2005 |