HRYClass II
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
21 CFR 888.3530 / Orthopedic
HRY is the FDA product code for Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, a class II device type, regulated under 21 CFR 888.3530. As of , FDA records hold 91 510(k) clearances under this code, the most recent dated , and 68 recalls.
Classification record
- Product code
- HRY
- Device name
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Regulation
- 21 CFR 888.3530
- 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
- 91
- Ingested recalls
- 68
Clearances, product code HRY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 1 |
| 1978 | 2 |
| 1979 | 4 |
| 1980 | 3 |
| 1981 | 5 |
| 1982 | 3 |
| 1983 | 1 |
| 1984 | 2 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 2 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 4 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 6 |
| 2002 | 6 |
| 2003 | 3 |
| 2004 | 5 |
| 2005 | 2 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 3 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
Applicants with the most clearances
Product code HRY| Applicant | Clearances |
|---|---|
| Zimmer GmbH | 12 |
| Howmedica Corp. | 11 |
| Wrightmedicaltechnologyinc | 6 |
| Depuy Orthopaedics Inc. | 5 |
| Biomet Manufacturing Corp | 4 |
| Osteonics Corp. | 4 |
| Depuy, Inc. | 3 |
| Depuy, Inc. | 3 |
| Intermedics Orthopedics | 3 |
| Richard'S Medical Equip., 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.