JDW — Pin, Fixation, Threaded Class II
FDA product code JDW covers "Pin, Fixation, Threaded", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JDW
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260073 | biodynamik | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | February 10, 2026 |
| K250316 | meduloc | Meduloc Intramedullary Fracture Fixation (IFF) System | October 29, 2025 |
| K241357 | biodynamik | XT3 System | January 22, 2025 |
| K223112 | smith and nephew | MAVERICK Mini External Fixation System | December 8, 2022 |
| K213874 | smith and nephew | MAVERICK External Fixation System | February 11, 2022 |
| K211508 | stryker | Steinmann Pins and Kirschner Wires | October 5, 2021 |
| K210784 | smith and nephew | Extended HA Half Pins | April 2, 2021 |
| K200933 | syntec scientific corporation | Syntec Non-Sterile Steinmann Pins System | May 5, 2020 |
| K191803 | tinavi (anhui) medical technologies co | Orthopedic Fixation Pin | April 14, 2020 |
| K192768 | eisertech | Temporary Fixation Pins | December 26, 2019 |
| K182171 | summit medventures | SMV Scientific K-Wire and Pins | October 25, 2018 |
| K163487 | vilex in tennessee | Ultima HA Coated Half Pins and Wire | February 13, 2017 |
| K150661 | citieffe | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | July 7, 2015 |
| K132820 | vilex | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | July 23, 2014 |
| K140875 | genossis | OPTOSSOL COMPRESSION DEVICE SYSTEM | May 30, 2014 |
| K131459 | aap implantate | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | October 17, 2013 |
| K130298 | biopro | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | June 18, 2013 |
| K120871 | smith and nephew | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | June 7, 2012 |
| K103001 | depuy orthopaedics | ROCKWOOD CLAVICLE PINS | February 17, 2011 |
| K102777 | merete medical | TWISTCUT ENDOSORB SCREWS | December 20, 2010 |