FDA 510(k) Applications for Medical Device Product Code "HTY"
(Pin, Fixation, Smooth)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K221283 | 4WEB Medical, Inc. | Hammertoe Truss System (HTS) | 09/06/2022 |
| K190926 | 4Web, Inc. | Hammertoe Truss System (HTS) | 07/23/2019 |
| K180087 | A.M. Surgical, Inc | A.M. Surgical Intramedullary Fixation Device | 05/18/2018 |
| K970013 | AAP GMBH AND CO. BETRIEBS KG | BIORIGID NAIL TIBIA | 03/13/1997 |
| K964500 | ACUMED, INC. | ACUMED TENSION BAND PIN | 12/09/1996 |
| K160264 | Additive Orthopaedics, LLC | Additive Orthopaedics Hammertoe Correction System | 06/01/2016 |
| K960482 | AMERICAN MEDICAL SPECIALTIES, INC. | K-WIRE | 04/09/1996 |
| K960483 | AMERICAN MEDICAL SPECIALTIES, INC. | STEINMAN PIN | 04/09/1996 |
| K121004 | APEX TOOLS & ORTHOPEDICS CO. | APEX KIRSCHNER WIRES AND STEINMANN PINS | 04/24/2012 |
| K112254 | APEX TOOLS & ORTHOPEDICS CO. | APEX KIRSCHNER WIRES AND STEINMANN PINS | 10/11/2011 |
| K071616 | ARC SURGICAL LLC. | ARC SURGICAL BIOTRAK PIN SYSTEM | 12/19/2007 |
| K094043 | AREX USA | LIGAMENTOTAXOR | 08/17/2010 |
| K122415 | AREX USA LLC | X-FIX DYNAMIC EXTERNAL DISTRACTOR | 03/15/2013 |
| K202777 | Armis Biopharma, Inc. | VeriFixxÖ Small Bone Implant | 11/17/2020 |
| K100926 | ARROW PRODUCTS, INC. | ARROWHEAD FIXATION DEVICE | 10/29/2010 |
| K112675 | ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC | ARROW-LOK DIGITAL SYSTEM | 12/12/2011 |
| K200068 | Arthrex Inc. | Arthrex DynaNite K-Wire | 06/29/2020 |
| K190287 | Arthrex Inc. | Arthrex DynaNite« PIP (Hammertoe) Implant | 05/03/2019 |
| K100652 | ARTHREX, INC. | ACL TIGHTROPE | 06/23/2010 |
| K101837 | ARTHREX, INC. | ACL TIGHTROPE DOUBLE BUNDLE | 12/28/2010 |
| K112990 | ARTHREX, INC. | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE | 12/19/2011 |
| K050259 | ARTHREX, INC. | ARTHREX BIO-PIN | 05/27/2005 |
| K143702 | Arthrex, Inc. | Arthrex Blunt Tip Screws with Fiber Tape | 04/09/2015 |
| K991971 | ARTHREX, INC. | ARTHREX CHONDRAL DART, MODEL AR-4005B-18 | 08/04/2000 |
| K063719 | ARTHREX, INC. | ARTHREX CROSSPIN, MODEL AR-1964P | 03/06/2007 |
| K052736 | ARTHREX, INC. | ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT | 11/03/2005 |
| K141577 | ARTHREX, INC. | ARTHREX PIP DART | 07/18/2014 |
| K170326 | Arthrex, Inc. | dynaMX Intramedullary Implant | 07/20/2017 |
| K110123 | ARTHREX, INC. | PCL TIGHTROPE | 04/28/2011 |
| K040500 | ARTHROTEK, INC. | ARTHROTEK LACTONAIL | 05/25/2004 |
| K014305 | ARTHROTEK, INC. | RESORBABLE LACTOSORB-L ACL CROSSPIN | 03/29/2002 |
| K151876 | Bio2 Technologies, Inc | Bio2 Fusion Implant System | 12/30/2015 |
| K091951 | BIOMEDICAL ENT., INC. | HAMMERLOCK | 02/19/2010 |
| K131640 | BIOMEDICAL ENT., INC. | SMOOTH OR THREADED METALLIC BONE FASTENER | 10/16/2013 |
| K133520 | BIOMEDICAL ENTERPRISES, INC | HAMMERLOCK 2 | 01/09/2014 |
| K022531 | BIOMET, INC. | 2MM PEDIATRIC FLEX NAIL | 08/26/2002 |
| K990291 | BIOMET, INC. | LACTOSORB BONE PIN | 03/23/1999 |
| K011522 | BIOMET, INC. | RESORBABLE BONE PINS | 07/31/2001 |
| K003659 | BIONX IMPLANTS, INC. | PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 | 02/20/2001 |
| K010983 | BIONX IMPLANTS, INC. | PLLA PIN | 06/13/2001 |
| K083490 | BIOPRO, INC. | BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 | 03/18/2009 |
| K061164 | BIORETEC LTD | ACTIVAPIN | 07/06/2006 |
| K071863 | BIORETEC LTD | ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) | 08/31/2007 |
| K080879 | BIORETEC LTD | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM | 06/24/2008 |
| K133950 | BIORETEC LTD. | ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) | 01/22/2014 |
| K010479 | BONUTTI RESEARCH, INC. | MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR | 05/08/2001 |
| K033717 | BONUTTI RESEARCH, INC. | TRANSET FRACTURE FIXATION SYSTEM | 02/25/2004 |
| K060283 | BONUTTI RESEARCH, INC. | TRANSET SYSTEM | 02/22/2006 |
| K142134 | CONMED CORPORATION, LARGO | C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES | 09/12/2014 |
| K060654 | DELTA SURGICAL INSTRUMENTS, INC. | DSI PINS AND WIRES | 04/28/2006 |
| K130105 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM | 05/17/2013 |
| K032687 | DEPUY ORTHOPAEDICS, INC. | ACE NANCY NAIL | 10/06/2003 |
| K960385 | DEPUY, INC. | STERILE KIRSCHNER WIRES AND STEINMANN PINS | 03/27/1996 |
| K231905 | Electro-Spec, Inc | Electro-Spec Steri-Caps | 08/14/2023 |
| K980854 | ENCORE ORTHOPEDICS, INC. | RETROGRADE PEDIATRIC NAIL | 08/11/1998 |
| K102215 | EVERGREEN ORTHOPEDIC RESEARCH LAB | KIRSCHNER WIRES, STEINMAN PINS | 11/09/2010 |
| K964087 | FERGUSON MEDICAL | BLOCK STOP WIRES | 11/25/1996 |
| K012161 | FIXANO SA | FLEX-NAILS | 08/24/2001 |
| K024185 | FUTURE MEDICAL SYSTEMS, SA | BIODHOC | 01/15/2004 |
| K142478 | Graham Medical Technologies, L.L.C. (d.b.a.GraMedica) | opti-Toe | 05/29/2015 |
| K013424 | HAND INNOVATIONS, INC. | INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND | 12/20/2001 |
| K041157 | HAND INNOVATIONS, INC. | MODIFICATION TO SMALL BONE FIXATION SYSTEM | 07/30/2004 |
| K033406 | HAND INNOVATIONS, INC. | SMALL BONE FIXATION SYSTEM | 01/15/2004 |
| K091955 | HOWMEDICA OSTEONICS CORP | STRYKER SONICPIN SYSTEM | 04/02/2010 |
| K033968 | HOWMEDICA OSTEONICS CORP. | HANSSON PIN SYSTEM | 02/20/2004 |
| K955806 | HOWMEDICA, INC. | HOWMEDICA BIOABSORBABLE PIN | 02/15/1996 |
| K002125 | IMPLANT RESOURCE, INC. | PINS AND WIRES | 10/11/2000 |
| K173616 | In2Bones SAS | DIP Arthrodesis System | 01/19/2018 |
| K153204 | IN2BONES SAS | In2Bones Kirschner wire | 02/01/2016 |
| K203698 | In2Bones USA, LLC | CoLink Sfx Implant System | 05/04/2021 |
| K031712 | INION LTD. | INION OTPS BIODEGRADABLE PIN | 08/28/2003 |
| K050275 | INION LTD. | MODIFICATION TO: INION OTPS BIODEGRADABLE PIN | 03/07/2005 |
| K133932 | INION OY | INION FREEDOMPIN | 04/11/2014 |
| K231147 | Intelivation | HammerdesisÖ Interphalangeal Fusion System | 09/14/2023 |
| K061607 | INTELLIGENT ORTHOPAEDICS LTD | STORM OPERATING KIT, MODEL 1-10-0 | 07/18/2006 |
| K960642 | LANDOS, INC. | NANCY NAIL | 05/17/1996 |
| K203475 | Limacorporate S.p.A. | LimaCorporate Kirschner Wire | 02/05/2021 |
| K041288 | LINVATEC BIOMATERIALS, INC. | MODIFICATION TO SMARTPIN | 06/10/2004 |
| K043106 | LINVATEC CORP. | PINN-ACL CROSSPIN | 01/19/2005 |
| K092038 | MEDARTIS AG | APTUS K-WIRE SYSTEM | 09/23/2009 |
| K991064 | MEDCANICA, INC. | METACARPAL FIXATION SYSTEM | 06/23/1999 |
| K994232 | MEDCANICA, INC. | PHALANGEAL FIXATION SYSTEM | 03/01/2000 |
| K102072 | MEMOMETAL TECHNOLOGIES | MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) | 11/03/2010 |
| K112197 | MEMOMETAL TECHNOLOGIES | MEMOMETAL INTRA-MEDULLARY BONE FASTENER | 11/17/2011 |
| K070598 | MEMOMETAL TECHNOLOGIES | MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE | 07/26/2007 |
| K152627 | METRIC MEDICAL DEVICES, INC. | IFS Fixation Scaffold System | 01/13/2016 |
| K013888 | MILTEX, INC. | FIXATION (STEINMANN) PINS | 05/01/2002 |
| K974291 | MITEK PRODUCTS | MITEK BTB ABSORBABLE (PLA) CROSS PIN | 03/05/1998 |
| K974341 | MITEK PRODUCTS | MITEK BTB ABSORBABLE (PLA) CROSS PIN | 04/16/1998 |
| K013781 | MITEK PRODUCTS | RIDIDFIX 2.7MM BTB CROSS PIN KIT | 02/06/2002 |
| K172485 | Newclip Technics | Footmotion HammerToe | 03/02/2018 |
| K022597 | NEWDEAL S.A. | K-FIX | 11/01/2002 |
| K022599 | NEWDEAL S.A. | NEWDEAL K WIRE | 10/30/2002 |
| K103623 | NEWDEAL SAS | NEWDEAL INTERPHALANGEAL IMPLANT | 03/20/2012 |
| K143049 | NOVASTEP | LYNC intramedullary implant | 02/19/2015 |
| K012125 | OPUS MEDICAL, INC. | OPUS MAGNUM ANCHOR & INSERTER | 09/17/2001 |
| K031083 | OPUS MEDICAL, INC. | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 | 06/12/2003 |
| K173051 | Orthofix Srl | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL | 11/16/2017 |
| K120165 | ORTHOHELIX SURGICAL DESIGNS, INC. | INTRAOSSEOUS FIXATION SYSTEM | 04/17/2012 |
| K141004 | ORTHOHELIX SURGICAL DESIGNS, INC. | INTRAOSSEOUS FIXATION SYSTEM | 08/21/2014 |
| K201838 | OrthoPediatrics Corp. | PediFlex Flexible Nail System | 01/29/2021 |
| K082375 | ORTHOPEDIATRICS, CORP. | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | 10/17/2008 |
| K081097 | ORTHOPEDIATRICS, LLC | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | 06/03/2008 |
| K070555 | ORTHOPRO LLC | ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES | 07/13/2007 |
| K971453 | ORTHOTECH | ORTHOTEC K-CAP SYSTEM | 06/24/1997 |
| K203465 | OSSIO Ltd. | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design | 01/06/2021 |
| K230750 | Ossio Ltd. | OSSIOfiber« Cannulated Trimmable Fixation Nail | 09/13/2023 |
| K190652 | Ossio Ltd. | OSSIOfiberÖ Hammertoe Fixation System/OSSIOfiberÖ Hammertoe Fixation Implant | 03/06/2020 |
| K201803 | Ossio Ltd. | OSSIOfiberÖ Hammertoe Fixation System/OSSIOfiberÖ Hammertoe Fixation Implant | 10/16/2020 |
| K181180 | Ossio Ltd. | OSSIOÖ Pin Product Family | 01/10/2019 |
| K971962 | OSTEONICS CORP. | OSTEO KIRSCHNER WIRES | 08/11/1997 |
| K213982 | Pacific Instruments | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | 02/17/2022 |
| K171715 | Paragon 28 | HammerTube System | 03/05/2018 |
| K183228 | Paragon 28, Inc. | HammerToe Compression System | 01/25/2019 |
| K160194 | Phalanx Innovations | StarFuse Interphalangeal Pin | 04/26/2016 |
| K163327 | PRECIFIT MEDICAL LTD | Precifit Medical Kirschner Wires | 05/08/2017 |
| K211789 | restor3d | restor3d Pin Implants | 01/04/2022 |
| K963367 | RMS DIV. | RMS K-WIRE | 10/30/1996 |
| K073674 | SIGNAL MEDICAL CORP. | BONE FIXATION WIRE (KIRSCHNER WIRE) | 03/24/2008 |
| K211439 | Skeletal Dynamics, Inc. | Small Bone Nailing System | 09/30/2021 |
| K051605 | SMALL BONE INNOVATIONS, LLC | SBI K-WIRES | 08/10/2005 |
| K041355 | SMITH & NEPHEW, INC. | HUMERAL STAPLE | 07/30/2004 |
| K100736 | SMT SCHILLING METALLTECHNIK GMBH | KIRSCHNER AND GUIDE WIRES | 09/10/2010 |
| K152662 | Spinal Resources Inc | S-Wire | 03/09/2016 |
| K082017 | STARR FRAME LLC | STARR FRAME STEINMANN PIN | 10/10/2008 |
| K030665 | STORK INSTRUMENTE GMBH | BONE WIRE | 03/25/2003 |
| K150416 | STRYKER ENDOSCOPY | ProCinch Adjustable Loop Device | 04/17/2015 |
| K201715 | Stryker GmbH | Smart Toe II, X Fuse | 08/05/2020 |
| K170418 | Stryker Trauma Gmbh | Stryker SonicPin System | 06/20/2017 |
| K143063 | STRYKER TRAUMA GMBH | Stryker SonicPin System, Stryker SonicAnchor System | 01/27/2015 |
| K982719 | SURGICRAFT LTD. | THE BONE TIE | 09/25/1998 |
| K133477 | SYNCHRO MEDICAL | TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS | 02/10/2014 |
| K983121 | SYNTEC SCIENTIFIC CORP. | NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 | 10/05/1998 |
| K003527 | SYNTHES (USA) | MODIFICATION TO SYNTHES (USA) POLYPIN | 04/09/2001 |
| K961608 | SYNTHES (USA) | SYNTHES (U.S.A.) POLYPIN | 05/09/1997 |
| K971783 | SYNTHES (USA) | SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM | 07/18/1997 |
| K973240 | SYNTHES (USA) | SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION | 11/20/1997 |
| K970733 | SYNTHES (USA) | SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM | 04/02/1997 |
| K161489 | SYNTORR INC | Syntorr K-wire and Pin System | 09/16/2016 |
| K961522 | SYNVASIVE TECHNOLOGY, INC. | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN | 09/23/1996 |
| K073311 | TAKIRON CO., LTD | OSTEOTRANS-OT PIN | 05/13/2008 |
| K070561 | TELEFLEX MEDICAL | KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES | 05/25/2007 |
| K121008 | TRILLIANT SURGICAL LTD | TRILLIANT SURGICAL K-WIRES | 06/04/2012 |
| K231339 | Tyber Medical, LLC | Tyber Medical Pin and Wire System (various) | 07/06/2023 |
| K970036 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | FIXATION PIN OR ROD | 03/25/1997 |
| K110047 | VERTICOR, LTD | VERTICOR K-WIRE SYSTEM | 02/28/2011 |
| K173013 | WishBone Medical, Inc. | WishBone K-Wire System | 12/14/2017 |
| K141714 | WRIGHT MEDICAL TECHNOLOGY, INC. | PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM | 10/24/2014 |
| K132895 | WRIGHT MEDICAL TECHNOLOGY, INC. | WMT IMPLANTABLE K-WIRE | 10/23/2013 |
| K220906 | Xiros Ltd | SECURE-LOCK | 07/22/2022 |
| K043339 | XTREMI-T, LLC | REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG | 04/18/2005 |
| K143618 | ZIMMER, INC. | Kirschner Wires, Steinmann Pins | 02/06/2015 |
| K150626 | Zimmer, Inc. | Rush Medullary Pins | 05/01/2015 |
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