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 |