MEHClass II
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
21 CFR 888.3353 / Orthopedic
MEH is the FDA product code for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a class II device type, regulated under 21 CFR 888.3353. As of , FDA records hold 160 510(k) clearances under this code, the most recent dated , and 196 recalls.
Classification record
- Product code
- MEH
- Device name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Regulation
- 21 CFR 888.3353
- 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
- 160
- Ingested recalls
- 197
Clearances, product code MEH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 14 |
| 1992 | 5 |
| 1993 | 4 |
| 1994 | 9 |
| 1995 | 11 |
| 1996 | 4 |
| 1997 | 6 |
| 1998 | 5 |
| 1999 | 6 |
| 2000 | 9 |
| 2001 | 1 |
| 2002 | 7 |
| 2003 | 1 |
| 2004 | 6 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 6 |
| 2009 | 6 |
| 2010 | 5 |
| 2011 | 5 |
| 2012 | 6 |
| 2013 | 1 |
| 2015 | 2 |
| 2016 | 6 |
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 6 |
| 2025 | 5 |
| 2026 | 1 |
Applicants with the most clearances
Product code MEH| Applicant | Clearances |
|---|---|
| Osteonics Corp. | 24 |
| Howmedica Osteonics Corp | 19 |
| Smith & Nephew, Inc. | 13 |
| Exactech, Inc. | 8 |
| Signature Orthopaedics Pty Limited | 8 |
| Aesculap Inc | 5 |
| Zimmer GmbH | 5 |
| Corin USA | 5 |
| Depuy, Inc. | 4 |
| Dow Corning Wright | 3 |
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.