ClearanceBrief
Panels › Orthopedic › Product code JDW · Class 2

Pin, Fixation, Threaded

Regulation 888.3040

1510(k)s in 12 months (94 all time)
0recalls in 12 months (100 all time)
73recalls that name a 510(k)
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Top companies in JDW

Company510(k)sRecalls
Smith & Nephew, Inc.853
Orthofix Srl223
Zimmer, Inc.120
Biomet, Inc.41
Depuy, Inc.50
Buckman Co., Inc.40
Synthes (Usa)40
Howmedica Corp.30
O'Tec Corp.30
Stryker Endoscopy30
Decided510(k)Device and applicantCode
Feb 10, 2026K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
Biodynamik, Inc.
JDW
Oct 29, 2025K250316Meduloc Intramedullary Fracture Fixation (IFF) System
Meduloc, LLC
JDW
Jan 22, 2025K241357XT3 System
Biodynamik, Inc.
JDW
Dec 8, 2022K223112MAVERICK Mini External Fixation System
Smith & Nephew, Inc.
JDW
Feb 11, 2022K213874MAVERICK External Fixation System
Smith & Nephew, Inc.
JDW
Oct 5, 2021K211508Steinmann Pins and Kirschner Wires
Stryker GmbH
JDW
Apr 2, 2021K210784Extended HA Half Pins
Smith & Nephew, Inc.
JDW
May 5, 2020K200933Syntec Non-Sterile Steinmann Pins System
Syntec Scientific Corporation, TW
JDW
Apr 14, 2020K191803Orthopedic Fixation Pin
Tinavi (Anhui) Medical Technologies Co., Ltd., CN
JDW
Dec 26, 2019K192768Temporary Fixation Pins
Eisertech, LLC
JDW
Oct 25, 2018K182171SMV Scientific K-Wire and Pins
Summit Medventures
JDW
Feb 13, 2017K163487Ultima HA Coated Half Pins and Wire
Vilex IN Tennessee, Inc.
JDW
Jul 7, 2015K150661ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
Citieffe S.R.L., IT
JDW
Jul 23, 2014K132820VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
Vilex, Inc.
JDW
May 30, 2014K140875OPTOSSOL COMPRESSION DEVICE SYSTEM
Genossis, LLC
JDW
Oct 17, 2013K131459AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
Aap Implantate AG, DE
JDW
Jun 18, 2013K130298BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
Biopro, Inc.
JDW
Jun 7, 2012K120871SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
Smith & Nephew, Inc.
JDW
Feb 17, 2011K103001ROCKWOOD CLAVICLE PINS
DePuy Orthopaedics, Inc.
JDW
Dec 20, 2010K102777TWISTCUT ENDOSORB SCREWS
Merete Medical GmbH, DE
JDW
Jul 2, 2010K100414PROTOE ENDOSORB SMALL HAMMER TOE PIN
Merete Medical GmbH, DE
JDW
Jun 16, 2009K083144ACUMED CLAVICLE SCREW SYSTEM
Acumed, LLC
JDW
Nov 8, 2007K072710NEXFIX COMPRESSION PIN
Nexa Orthopedics, Inc.
JDW
Aug 8, 2007K071540SBI TITANIUM THREADED PIN
Small Bone Innovations, Inc.
JDW
Jul 26, 2006K061599PIN SCREW
Bk Meditech, Co., Ltd., KR
JDW
Jul 7, 2006K061493APEX PINS
Stryker Howmedica Osteonics
JDW
Jul 6, 2006K061498ALLOFIX ANCHOR, 5.0 MM ANCHOR
Musculoskeletal Transplant Foundation
JDW
Jan 13, 2006K053513T-PIN
Union Surgical, LLC
JDW
Sep 6, 2005K051740TAPERED COMPRESSION PIN
Nexa Orthopedics, Inc.
JDW
Apr 12, 2004K040765SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
Synthes (Usa)
JDW
Jan 13, 2004K033289MODIFICATION TO JET-X HA COATED HALF PINS
Smith & Nephew, Inc.
JDW
Oct 22, 2003K032532TARAS THREADED FIXATION PIN
Union Surgical, LLC
JDW
Jun 24, 2003K031154SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
Sintea Biotech, Inc.
JDW
Mar 6, 2003K030336KMEDIC EXTERNAL FIXATION DEVICES
Teleflex Medical Group
JDW
Feb 5, 2003K023921JET-X HA COATED HALF PINS
Smith & Nephew, Inc.
JDW
Oct 9, 2002K023134JET-X TIN COATED HALF PINS
Smith & Nephew, Inc.
JDW
May 13, 2002K021182RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
Biomet, Inc.
JDW
Mar 15, 2002K020097STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
Stryker Endoscopy
JDW
Sep 28, 2001K012270STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
Stryker Endoscopy
JDW
Sep 6, 2001K011875MODIFICATION TO THE TAC' PIN
New Deal, S.A.
JDW
Jul 20, 2001K011319STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
Stryker Endoscopy
JDW
Jun 19, 2001K011137RESORBABLE HAMMERTOE PIN
Biomet, Inc.
JDW
May 4, 2001K011136APEX FIXATION PINS
Howmedica Osteonics Corp.
JDW
Nov 20, 2000K0026054.0/2.5 MM SELF-DRILLING SCHANZ SCREW
Synthes (Usa)
JDW
Nov 3, 2000K003294BIOMET LATERAL TROCH PLATE
Biomet, Inc.
JDW
Nov 2, 2000K003131MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
Biomet, Inc.
JDW
Aug 24, 2000K001720SYNTHES SACRAL BAR SYSTEM
Synthes (Usa)
JDW
Jul 12, 2000K001886APEX FIXATION PINS
Howmedica Osteonics Corp.
JDW
Jul 7, 2000K001228EXTERNAL FIXATION ANCHOR PIN
Immedica, Inc.
JDW
Feb 18, 2000K994143SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
Smith & Nephew, Inc.
JDW

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