KRRClass II
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
21 CFR 888.3540 / Orthopedic
KRR is the FDA product code for Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer, a class II device type, regulated under 21 CFR 888.3540. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- KRR
- Device name
- Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- Regulation
- 21 CFR 888.3540
- 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
- 27
- Ingested recalls
- 9
Clearances, product code KRR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 2000 | 4 |
| 2001 | 1 |
| 2002 | 2 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 3 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code KRR| Applicant | Clearances |
|---|---|
| Howmedica Osteonics Corp | 4 |
| Arthrosurface, Inc. | 3 |
| Zimmer GmbH | 3 |
| Biomet Manufacturing Corp | 2 |
| Mako Surgical Corp. | 2 |
| Accelerated Innovation, LLC | 1 |
| Arthrex GmbH | 1 |
| Episurf Medical Inc | 1 |
| Global Orthopaedic Technology, USA, Inc. | 1 |
| Howmedica Osteonics Corp., dba Stryker Orthopaedics | 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.