FDA 510(k) Applications for Medical Device Product Code "HTY"
(Pin, Fixation, Smooth)

FDA 510(k) Number Applicant Device Name Decision Date
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
K922766 ACUFEX MICROSURGICAL, INC. ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION 07/09/1993
K931836 ACUFEX MICROSURGICAL, INC. ACUFEX SMOOTH AND THREADED PINS 06/28/1994
K964500 ACUMED, INC. ACUMED TENSION BAND PIN 12/09/1996
K943856 ACUMED, INC. FIXATION PINS/WIRES 07/06/1995
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
K100926 ARROW PRODUCTS, INC. ARROWHEAD FIXATION DEVICE 10/29/2010
K112675 ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC ARROW-LOK DIGITAL SYSTEM 12/12/2011
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
K930969 BAUMER ORTOPEDIA LTD. BAUMER PINS 03/29/1994
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
K953194 BIOMET, INC. LACTOSORB BONE PIN 10/31/1995
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
K925098 BIOSCIENCE, INC. BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE 07/19/1994
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
K895079 BUCKMAN CO., INC. ACE BEADED K-WIRES ACE OLIVE WIRES 09/13/1989
K860590 BUCKMAN CO., INC. ACE UNILATERAL FIXATOR 03/07/1986
K142134 CONMED CORPORATION, LARGO C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES 09/12/2014
K890902 DAVIS & GECK, INC. BIOFIX* BIODEGRADABLE FIXATION ROD 11/03/1989
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
K863119 DOWNS SURGICAL LTD. CANNULATED LAG SCREWS 09/03/1986
K911375 DR.M.A.GALLUZZO G-PIN 09/23/1991
K980854 ENCORE ORTHOPEDICS, INC. RETROGRADE PEDIATRIC NAIL 08/11/1998
K833952 ETHICON, INC. FIXATION PINS 02/10/1984
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
K954543 GENESIS ORTHOPEDICS, INC. GO UNIVERSALK-WIRE FLUTED DRILL 12/08/1995
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
K945639 HOWMEDICA CORP. SPETZLER PIN 04/14/1995
K954001 HOWMEDICA CORP. SPETZLER PIN 10/26/1995
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
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
K061607 INTELLIGENT ORTHOPAEDICS LTD STORM OPERATING KIT, MODEL 1-10-0 07/18/2006
K940669 J.B.S., S.A. J.B.S. B.A.C. PIN 11/14/1994
K940673 J.B.S., S.A. J.B.S. SELF-TAPPING THREADED PIN 11/14/1994
K940666 J.B.S., S.A. JBS SMOOTH FIXATION PIN 11/14/1994
K864912 JOHNSON & JOHNSON PROFESSIONALS, INC. PDS (POLYDIOXANON) ABSORBABLE PIN 07/09/1987
K850026 KIRKSTIL CORP., INC. ORTHOPEDIC IMPLANT NAILS & PINS 05/20/1985
K831005 KIRSCHNER MEDICAL CORP. WIRE & STEINMAN PINS 05/18/1983
K960642 LANDOS, INC. NANCY NAIL 05/17/1996
K041288 LINVATEC BIOMATERIALS, INC. MODIFICATION TO SMARTPIN 06/10/2004
K043106 LINVATEC CORP. PINN-ACL CROSSPIN 01/19/2005
K901273 MED-TEK CORP. L.M.S. SELF-DETACHABLE BROACH WITH STOP 06/05/1990
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
K863734 MICRO-AIRE SURGICAL INSTRUMENTS, INC. STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS 10/20/1986
K872842 MILITARY ENGINEERING, INC. PIN, HIP, KNOWLES 08/07/1987
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
K905345 O'TEC CORP. K-WIRE 12/11/1990
K905341 O'TEC CORP. RUSH PIN 12/11/1990
K905337 O'TEC CORP. STEINMAN PIN 12/11/1990
K941434 OMEGA SURGICAL INSTRUMENTS, INC. K-WIRES AND STEINMANN PINS 10/03/1994
K903264 ONYX MEDICAL CORP. K-WIRE 07/30/1990
K903265 ONYX MEDICAL CORP. STEINMAN PIN 07/30/1990
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
K931697 ORTHOLOGIC CORP. FIXATION PIN 05/12/1994
K874913 ORTHOMET, INC. ORTHOMET PIN SYSTEM 01/07/1988
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
K181180 Ossio Ltd. OSSIOÖ Pin Product Family 01/10/2019
K922193 OSTEO AG OSTEO KIRSCHNER WIRE 07/23/1992
K922194 OSTEO AG OSTEO STEINMANN PIN 07/23/1992
K925301 OSTEO TECHNOLOGY, INC. OTI ORTHOPEDIC FASTENER SYSTEM 03/16/1993
K932348 OSTEOMED CORP. ORTHOPEDIC SMOOTH PIN FIXATION 03/01/1994
K971962 OSTEONICS CORP. OSTEO KIRSCHNER WIRES 08/11/1997
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
K963367 RMS DIV. RMS K-WIRE 10/30/1996
K073674 SIGNAL MEDICAL CORP. BONE FIXATION WIRE (KIRSCHNER WIRE) 03/24/2008
K911452 SIMPEX, INC. FIXATION PIN 04/12/1991
K911505 SIMPEX, INC. FIXATION WIRE 04/12/1991
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
K771418 STRYKER CORP. PIN RETRACTORS 09/22/1977
K150416 STRYKER ENDOSCOPY ProCinch Adjustable Loop Device 04/17/2015
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
K940109 TAVA SURGICAL INSTRUMENTS TAVA K-WIRE 02/22/1994
K070561 TELEFLEX MEDICAL KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES 05/25/2007
K852563 THE HUXLEY INSTRUMENT CORP. PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG 06/28/1985
K852562 THE HUXLEY INSTRUMENT CORP. PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG 06/28/1985
K852561 THE HUXLEY INSTRUMENT CORP. PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG 06/28/1985
K852560 THE HUXLEY INSTRUMENT CORP. PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONG 06/28/1985
K121008 TRILLIANT SURGICAL LTD TRILLIANT SURGICAL K-WIRES 06/04/2012
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
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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