JDW · Class II · 21 CFR 888.3040

FDA Product Code JDW: Pin, Fixation, Threaded

Under FDA product code JDW, threaded fixation pins are cleared for bone stabilization in orthopedic and trauma surgery.

Unlike smooth Kirschner wires, threaded pins have a helical thread that engages bone and resists pullout, providing more stable fixation for small bone fragments, external fixator frames, and temporary stabilization of fractures pending definitive repair.

JDW devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Smith & Nephew, Inc., Depuy, Inc. and Buckman Co., Inc..

94
Total
94
Cleared
78d
Avg days
1976
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 184d recently vs 75d historically

FDA 510(k) Cleared Pin, Fixation, Threaded Devices (Product Code JDW)

94 devices
1–24 of 94
Cleared Feb 10, 2026
XT3 System
K260073
Biodynamik, Inc.
Orthopedic · 32d
Cleared Oct 29, 2025
Meduloc Intramedullary Fracture Fixation (IFF) System
K250316
Meduloc, LLC
Orthopedic · 267d
Cleared Jan 22, 2025
XT3 System
K241357
Biodynamik, Inc.
Orthopedic · 253d
Cleared Dec 08, 2022
MAVERICK Mini External Fixation System
K223112
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Feb 11, 2022
MAVERICK External Fixation System
K213874
Smith & Nephew, Inc.
Orthopedic · 60d
Cleared Oct 05, 2021
Steinmann Pins and Kirschner Wires
K211508
Stryker GmbH
Orthopedic · 144d
Cleared Apr 02, 2021
Extended HA Half Pins
K210784
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared May 05, 2020
Syntec Non-Sterile Steinmann Pins System
K200933
Syntec Scientific Corporation
Orthopedic · 28d
Cleared Apr 14, 2020
Orthopedic Fixation Pin
K191803
Tinavi (Anhui) Medical Technologies Co., Ltd.
Orthopedic · 286d
Cleared Dec 26, 2019
Temporary Fixation Pins
K192768
Eisertech, LLC
Orthopedic · 87d
Cleared Oct 25, 2018
SMV Scientific K-Wire and Pins
K182171
Summit Medventures
Orthopedic · 76d
Cleared Feb 13, 2017
Ultima HA Coated Half Pins and Wire
K163487
Vilex IN Tennessee, Inc.
Orthopedic · 63d
Cleared Jul 07, 2015
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
K150661
Citieffe S.R.L.
Orthopedic · 116d
Cleared Jul 23, 2014
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
K132820
Vilex, Inc.
Orthopedic · 317d
Cleared May 30, 2014
OPTOSSOL COMPRESSION DEVICE SYSTEM
K140875
Genossis, LLC
Orthopedic · 56d
Cleared Oct 17, 2013
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
K131459
Aap Implantate AG
Orthopedic · 150d
Cleared Jun 18, 2013
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
K130298
Biopro, Inc.
Orthopedic · 131d
Cleared Jun 07, 2012
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Feb 17, 2011
ROCKWOOD CLAVICLE PINS
K103001
DePuy Orthopaedics, Inc.
Orthopedic · 134d
Cleared Dec 20, 2010
TWISTCUT ENDOSORB SCREWS
K102777
Merete Medical GmbH
Orthopedic · 87d
Cleared Jul 02, 2010
PROTOE ENDOSORB SMALL HAMMER TOE PIN
K100414
Merete Medical GmbH
Orthopedic · 136d
Cleared Jun 16, 2009
ACUMED CLAVICLE SCREW SYSTEM
K083144
Acumed, LLC
Orthopedic · 236d
Cleared Nov 08, 2007
NEXFIX COMPRESSION PIN
K072710
Nexa Orthopedics, Inc.
Orthopedic · 44d
Cleared Aug 08, 2007
SBI TITANIUM THREADED PIN
K071540
Small Bone Innovations, Inc.
Orthopedic · 64d

About Product Code JDW - Regulatory Context

510(k) Submission Activity

94 total 510(k) submissions under product code JDW since 1976, with 94 receiving FDA clearance (average review time: 78 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JDW Product Code

Recent submissions under JDW have taken an average of 184 days to reach a decision - up from 75 days historically. Manufacturers should account for longer review timelines in current project planning.

JDW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →