HSXClass II
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
21 CFR 888.3520 / Orthopedic
HSX is the FDA product code for Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, a class II device type, regulated under 21 CFR 888.3520. As of , FDA records hold 115 510(k) clearances under this code, the most recent dated , and 104 recalls.
Classification record
- Product code
- HSX
- Device name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Regulation
- 21 CFR 888.3520
- 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
- 115
- Ingested recalls
- 104
Clearances, product code HSX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1983 | 1 |
| 1985 | 5 |
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 4 |
| 1991 | 4 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 3 |
| 1996 | 1 |
| 1999 | 1 |
| 2001 | 2 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 6 |
| 2008 | 4 |
| 2009 | 2 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 5 |
| 2013 | 2 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 5 |
| 2018 | 2 |
| 2019 | 7 |
| 2020 | 4 |
| 2021 | 7 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 4 |
| 2026 | 1 |
Applicants with the most clearances
Product code HSX| Applicant | Clearances |
|---|---|
| Smith & Nephew, Inc. | 13 |
| Zimmer GmbH | 12 |
| ConforMIS, Inc. | 8 |
| Bodycad Laboratories, Inc. | 7 |
| Mako Surgical Corp. | 6 |
| Depuy, Inc. | 5 |
| Howmedica Corp. | 5 |
| Medacta International SA | 5 |
| Dow Corning Wright | 4 |
| Materialise N.V. | 4 |
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.