FDA 510(k) Applications for Medical Device Product Code "JDW"
(Pin, Fixation, Threaded)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K131459 | AAP IMPLANTATE AG | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | 10/17/2013 |
| K083144 | ACUMED LLC | ACUMED CLAVICLE SCREW SYSTEM | 06/16/2009 |
| K980788 | ALPHATEC MFG., INC. | ALPHATEC WIRE EXTERNAL FIXATION SYSTEM | 05/22/1998 |
| K981716 | AVANTA ORTHOPAEDICS, INC. | EXTERNAL FIXATION | 07/17/1998 |
| K974911 | AVANTA ORTHOPAEDICS, INC. | EXTERNAL FIXATOR | 03/16/1998 |
| K003294 | BIOMET, INC. | BIOMET LATERAL TROCH PLATE | 11/03/2000 |
| K003131 | BIOMET, INC. | MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT | 11/02/2000 |
| K021182 | BIOMET, INC. | RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR | 05/13/2002 |
| K011137 | BIOMET, INC. | RESORBABLE HAMMERTOE PIN | 06/19/2001 |
| K130298 | BIOPRO, INC. | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | 06/18/2013 |
| K061599 | BK MEDITECH CO., LTD. | PIN SCREW | 07/26/2006 |
| K990353 | BREGMA INTERNATIONAL TRADING COMPANY LTD. | STAINLESS STEEL FIXATION PINS | 06/01/1999 |
| K150661 | CITIEFFE s.r.l | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | 07/07/2015 |
| K103001 | DEPUY ORTHOPAEDICS, INC. | ROCKWOOD CLAVICLE PINS | 02/17/2011 |
| K963973 | DEPUY, INC. | DEPUY CANNULATED CROSS PIN SCREW SYSTEM | 12/16/1996 |
| K991649 | DEPUY, INC. | DEPUY ROCKWOOD CLAVICLE PIN | 07/14/1999 |
| K192768 | EiserTech, LLC | Temporary Fixation Pins | 12/26/2019 |
| K140875 | GENOSSIS, LLC | OPTOSSOL COMPRESSION DEVICE SYSTEM | 05/30/2014 |
| K992970 | HAND BIOMECHANICS LAB, INC. | DIGIT WIDGET | 11/08/1999 |
| K982068 | HOWMEDICA CORP. | HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM | 08/31/1998 |
| K001886 | HOWMEDICA OSTEONICS CORP. | APEX FIXATION PINS | 07/12/2000 |
| K011136 | HOWMEDICA OSTEONICS CORP. | APEX FIXATION PINS | 05/04/2001 |
| K001228 | IMMEDICA, INC. | EXTERNAL FIXATION ANCHOR PIN | 07/07/2000 |
| K961920 | MEDICINE LODGE, INC. | CROSS PIN | 09/17/1996 |
| K100414 | MERETE MEDICAL GMBH | PROTOE ENDOSORB SMALL HAMMER TOE PIN | 07/02/2010 |
| K102777 | MERETE MEDICAL GMBH | TWISTCUT ENDOSORB SCREWS | 12/20/2010 |
| K061498 | MUSCULOSKELETAL TRANSPLANT FOUNDATION | ALLOFIX ANCHOR, 5.0 MM ANCHOR | 07/06/2006 |
| K011875 | NEWDEAL S.A. | MODIFICATION TO THE TAC' PIN | 09/06/2001 |
| K993910 | NEWDEAL S.A. | TAC' PIN | 02/01/2000 |
| K072710 | NEXA ORTHOPEDICS, INC. | NEXFIX COMPRESSION PIN | 11/08/2007 |
| K051740 | NEXA ORTHOPEDICS, INC. | TAPERED COMPRESSION PIN | 09/06/2005 |
| K974186 | ORTHOFIX SRL | ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING | 03/18/1998 |
| K955848 | ORTHOFIX, INC. | ORTHOFIX MODULSYSTEM | 03/20/1996 |
| K963433 | ORTHOPAEDIC BIOSYSTEMS, LTD. | THREADED FIXATION PIN | 11/06/1996 |
| K964893 | OSTEONICS CORP. | HANSSON PIN SYSTEM | 02/28/1997 |
| K960023 | PROMEX, INC. | KIRSHNER WIRES (K-WIRE) & STEINMANN PINS | 03/18/1996 |
| K982931 | SGARLATO LABORATORIES, INC. | THREADED FIXATION PIN | 10/21/1998 |
| K031154 | SINTEA BIOTECH, INC. | SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X | 06/24/2003 |
| K071540 | SMALL BONE INNOVATIONS INC. | SBI TITANIUM THREADED PIN | 08/08/2007 |
| K210784 | Smith & Nephew, Inc. | Extended HA Half Pins | 04/02/2021 |
| K023921 | SMITH & NEPHEW, INC. | JET-X HA COATED HALF PINS | 02/05/2003 |
| K023134 | SMITH & NEPHEW, INC. | JET-X TIN COATED HALF PINS | 10/09/2002 |
| K213874 | Smith & Nephew, Inc. | MAVERICK External Fixation System | 02/11/2022 |
| K223112 | Smith & Nephew, Inc. | MAVERICK Mini External Fixation System | 12/08/2022 |
| K033289 | SMITH & NEPHEW, INC. | MODIFICATION TO JET-X HA COATED HALF PINS | 01/13/2004 |
| K994143 | SMITH & NEPHEW, INC. | SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] | 02/18/2000 |
| K120871 | SMITH & NEPHEW, INC. | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | 06/07/2012 |
| K970713 | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | COMPASS UNIVERSAL HINGE | 04/03/1997 |
| K970751 | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | HEIDELBERG EXTERNAL FIXATOR | 04/16/1997 |
| K012270 | Stryker Endoscopy | STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM | 09/28/2001 |
| K020097 | Stryker Endoscopy | STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM | 03/15/2002 |
| K011319 | Stryker Endoscopy | STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX | 07/20/2001 |
| K211508 | Stryker GmbH | Steinmann Pins and Kirschner Wires | 10/05/2021 |
| K061493 | STRYKER HOWMEDICA OSTEONICS | APEX PINS | 07/07/2006 |
| K182171 | Summit MedVentures | SMV Scientific K-Wire and Pins | 10/25/2018 |
| K983757 | SYNTEC SCIENTIFIC CORP. | SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 | 12/04/1998 |
| K200933 | Syntec Scientific Corporation | Syntec Non-Sterile Steinmann Pins System | 05/05/2020 |
| K002605 | SYNTHES (USA) | 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW | 11/20/2000 |
| K970097 | SYNTHES (USA) | PROXIMAL FEMORAL NAIL (PFN) SYSTEM | 03/13/1997 |
| K040765 | SYNTHES (USA) | SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS | 04/12/2004 |
| K001720 | SYNTHES (USA) | SYNTHES SACRAL BAR SYSTEM | 08/24/2000 |
| K030336 | TELEFLEX MEDICAL GROUP | KMEDIC EXTERNAL FIXATION DEVICES | 03/06/2003 |
| K191803 | Tinavi (Anhui) Medical Technologies Co., Ltd. | Orthopedic Fixation Pin | 04/14/2020 |
| K053513 | UNION SURGICAL LLC | T-PIN | 01/13/2006 |
| K032532 | UNION SURGICAL LLC | TARAS THREADED FIXATION PIN | 10/22/2003 |
| K163487 | Vilex in Tennessee, Inc | Ultima HA Coated Half Pins and Wire | 02/13/2017 |
| K132820 | VILEX, INC. | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | 07/23/2014 |
| K955780 | ZIMMER, INC. | RIGIDYNE A EXTERNAL FIXATION SYSTEM | 02/09/1996 |
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