JDWClass II
Pin, Fixation, Threaded
21 CFR 888.3040 / Orthopedic
JDW is the FDA product code for Pin, Fixation, Threaded, a class II device type, regulated under 21 CFR 888.3040. As of , FDA records hold 94 510(k) clearances under this code, the most recent dated , and 100 recalls.
Classification record
- Product code
- JDW
- Device name
- Pin, Fixation, Threaded
- 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
- 94
- Ingested recalls
- 100
Clearances, product code JDW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 1 |
| 1984 | 3 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 1 |
| 1990 | 4 |
| 1991 | 1 |
| 1994 | 1 |
| 1995 | 5 |
| 1996 | 6 |
| 1997 | 4 |
| 1998 | 7 |
| 1999 | 3 |
| 2000 | 8 |
| 2001 | 5 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code JDW| Applicant | Clearances |
|---|---|
| Smith & Nephew, Inc. | 8 |
| Zimmer GmbH | 5 |
| Buckman Co., Inc. | 4 |
| Depuy, Inc. | 4 |
| Stryker Corp. | 4 |
| Synthes (USA) Products LLC | 4 |
| Howmedica Corp. | 3 |
| Howmedica Osteonics Corp | 3 |
| O'Tec Corp. | 3 |
| Avanta Orthopaedics, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 3D MEDICAL MANUFACTURING, Inc. (dba Tecomet)
- AAP Implantate AG
- Acumed LLC
- Addn Solutions GmbH & Co. KG
- Aike (Shanghai) Medical Instrument Co., Ltd.
- Apex (Guangzhou) Tools & Orthopedics Company
- ARCH Medical Solutions - Elmhurst
- ARCH Medical Solutions - Memphis
- Arthrex GmbH
- Arthrex Manufacturing Inc.
- Arvato USA LLC
- Autocam Medical
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
