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 Synthes (Usa).

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 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 Apr 12, 2004
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K040765
Synthes (Usa)
Orthopedic · 18d
Cleared Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289
Smith & Nephew, Inc.
Orthopedic · 91d
Cleared Feb 05, 2003
JET-X HA COATED HALF PINS
K023921
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared May 13, 2002
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K021182
Biomet, Inc.
Orthopedic · 28d
Cleared Jun 19, 2001
RESORBABLE HAMMERTOE PIN
K011137
Biomet, Inc.
Orthopedic · 67d
Cleared May 04, 2001
APEX FIXATION PINS
K011136
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Nov 20, 2000
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K002605
Synthes (Usa)
Orthopedic · 90d
Cleared Nov 03, 2000
BIOMET LATERAL TROCH PLATE
K003294
Biomet, Inc.
Orthopedic · 14d
Cleared Nov 02, 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131
Biomet, Inc.
Orthopedic · 27d
Cleared Aug 24, 2000
SYNTHES SACRAL BAR SYSTEM
K001720
Synthes (Usa)
Orthopedic · 79d

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 →