KWZClass II
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
21 CFR 888.3310 / Orthopedic
KWZ is the FDA product code for Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, a class II device type, regulated under 21 CFR 888.3310. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 19 recalls.
Classification record
- Product code
- KWZ
- Device name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Regulation
- 21 CFR 888.3310
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 34
- Ingested recalls
- 20
Clearances, product code KWZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1987 | 1 |
| 1989 | 1 |
| 1995 | 1 |
| 2002 | 4 |
| 2003 | 4 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 7 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code KWZ| Applicant | Clearances |
|---|---|
| Zimmer GmbH | 7 |
| Smith & Nephew, Inc. | 6 |
| Howmedica Osteonics Corp | 4 |
| Depuy Orthopaedics Inc. | 3 |
| Encore Medical, LP | 3 |
| Exactech, Inc. | 2 |
| Osteonics Corp. | 2 |
| Biomet Orthopedics, Inc. | 1 |
| Centerpulse Orthopedics, Inc. | 1 |
| Depuy Ireland UC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.