JDW · Pin, Fixation, Threaded
Orthopedic · 21 CFR 888.3040 · Class 2
Overview
| Product Code | JDW |
|---|---|
| Device Name | Pin, Fixation, Threaded |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 94)
Showing 20 most recent of 94 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | Feb 10, 2026 | SESE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | Oct 29, 2025 | SESE |
| K241357 | XT3 System | Biodynamik, Inc. | Jan 22, 2025 | SESE |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | Dec 8, 2022 | SESE |
| K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | Feb 11, 2022 | SESE |
| K211508 | Steinmann Pins and Kirschner Wires | Stryker GmbH | Oct 5, 2021 | SESE |
| K210784 | Extended HA Half Pins | Smith & Nephew, Inc. | Apr 2, 2021 | SESE |
| K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | May 5, 2020 | SESE |
| K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | Apr 14, 2020 | SESE |
| K192768 | Temporary Fixation Pins | Eisertech, LLC | Dec 26, 2019 | SESE |
| K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | Oct 25, 2018 | SESE |
| K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | Feb 13, 2017 | SESE |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | Jul 7, 2015 | SESE |
| K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | Vilex, Inc. | Jul 23, 2014 | SESE |
| K140875 | OPTOSSOL COMPRESSION DEVICE SYSTEM | Genossis, LLC | May 30, 2014 | SESE |
| K131459 | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | Aap Implantate AG | Oct 17, 2013 | SESE |
| K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | Biopro, Inc. | Jun 18, 2013 | SESE |
| K120871 | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | Smith & Nephew, Inc. | Jun 7, 2012 | SESE |
| K103001 | ROCKWOOD CLAVICLE PINS | DePuy Orthopaedics, Inc. | Feb 17, 2011 | SESE |
| K102777 | TWISTCUT ENDOSORB SCREWS | Merete Medical GmbH | Dec 20, 2010 | SESE |
Top Applicants
- Smith & Nephew, Inc. — 8 clearances
- Depuy, Inc. — 5 clearances
- Biomet, Inc. — 4 clearances
- Buckman Co., Inc. — 4 clearances
- Synthes (Usa) — 4 clearances
