HTYClass II
Pin, Fixation, Smooth
21 CFR 888.3040 / Orthopedic
HTY is the FDA product code for Pin, Fixation, Smooth, a class II device type, regulated under 21 CFR 888.3040. As of , FDA records hold 205 510(k) clearances under this code, the most recent dated , and 32 recalls.
Classification record
- Product code
- HTY
- Device name
- Pin, Fixation, Smooth
- Regulation
- 21 CFR 888.3040
- 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
- 205
- Ingested recalls
- 32
Clearances, product code HTY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 5 |
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 6 |
| 1991 | 3 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 10 |
| 1995 | 5 |
| 1996 | 9 |
| 1997 | 8 |
| 1998 | 5 |
| 1999 | 2 |
| 2000 | 3 |
| 2001 | 8 |
| 2002 | 6 |
| 2003 | 4 |
| 2004 | 8 |
| 2005 | 6 |
| 2006 | 4 |
| 2007 | 6 |
| 2008 | 6 |
| 2009 | 2 |
| 2010 | 9 |
| 2011 | 6 |
| 2012 | 4 |
| 2013 | 4 |
| 2014 | 8 |
| 2015 | 8 |
| 2016 | 6 |
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 4 |
| 2020 | 5 |
| 2021 | 5 |
| 2022 | 4 |
| 2023 | 5 |
| 2024 | 1 |
| 2025 | 5 |
| 2026 | 1 |
Applicants with the most clearances
Product code HTY| Applicant | Clearances |
|---|---|
| Arthrex GmbH | 13 |
| Zimmer GmbH | 7 |
| OSSIO, Ltd. | 6 |
| Synthes (USA) Products LLC | 5 |
| Bioretec Ltd. | 4 |
| Orthopediatrics Corp | 4 |
| The Huxley Instrument Corp. | 4 |
| Bonutti Research, Inc. | 3 |
| Hand Innovations, Inc. | 3 |
| Howmedica Corp. | 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.