KROClass II
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
21 CFR 888.3510 / Orthopedic
KRO is the FDA product code for Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, a class II device type, regulated under 21 CFR 888.3510. As of , FDA records hold 87 510(k) clearances under this code, the most recent dated , and 123 recalls.
Classification record
- Product code
- KRO
- Device name
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Regulation
- 21 CFR 888.3510
- 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
- 87
- Ingested recalls
- 124
Clearances, product code KRO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 2 |
| 1982 | 4 |
| 1983 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1996 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 4 |
| 2001 | 6 |
| 2002 | 7 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 6 |
| 2016 | 3 |
| 2017 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 1 |
Applicants with the most clearances
Product code KRO| Applicant | Clearances |
|---|---|
| Zimmer GmbH | 15 |
| Howmedica Osteonics Corp | 9 |
| Biomet Manufacturing Corp | 5 |
| Howmedica Osteonics Corp., dba Stryker Orthopaedics | 5 |
| Stanmore Implants Worldwide, Ltd. | 5 |
| Waldemar Link GmbH & Co. KG | 5 |
| Medacta International SA | 4 |
| Plus Orthopedics | 4 |
| Wrightmedicaltechnologyinc | 3 |
| Biomet Orthopedics, Inc. | 2 |
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.