LWJClass II
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
21 CFR 888.3360 / Orthopedic
LWJ is the FDA product code for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a class II device type, regulated under 21 CFR 888.3360. As of , FDA records hold 81 510(k) clearances under this code, the most recent dated , and 26 recalls.
Classification record
- Product code
- LWJ
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Regulation
- 21 CFR 888.3360
- 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
- 81
- Ingested recalls
- 26
Clearances, product code LWJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 9 |
| 1990 | 4 |
| 1991 | 4 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 10 |
| 1997 | 4 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 10 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 6 |
| 2004 | 1 |
| 2005 | 4 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
Applicants with the most clearances
Product code LWJ| Applicant | Clearances |
|---|---|
| Plus Orthopedics | 7 |
| Osteonics Corp. | 6 |
| Globus Medical, Inc. | 5 |
| Encore Orthopedics, Inc. | 4 |
| Aesculap Inc | 3 |
| Depuy, Inc. | 3 |
| Hayes Medical, Inc. | 3 |
| Howmedica Corp. | 3 |
| Intermedics Orthopedics | 3 |
| Mizuho Orthopedic Systems Inc | 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.