Panels › Orthopedic › Product code HTY · Class 2
Pin, Fixation, Smooth
Regulation 888.3040
3510(k)s in 12 months (206 all time)
1recalls in 12 months (32 all time)
27recalls that name a 510(k)
Top companies in HTY
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 14 |
| Arthrex, Inc. | 13 | 0 |
| Biomet, Inc. | 5 | 2 |
| OSSIO , Ltd. | 6 | 0 |
| Synthes (Usa) | 5 | 0 |
| Bioretec, Ltd. | 4 | 0 |
| The Huxley Instrument Corp. | 4 | 0 |
| OrthoPediatrics Corp. | 4 | 0 |
| Paragon 28 | 3 | 1 |
| Smith & Nephew, Inc. | 1 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2015 | K143702 | Arthrex Blunt Tip Screws with Fiber Tape Arthrex, Inc. | HTY |
| Feb 19, 2015 | K143049 | LYNC intramedullary implant Novastep, FR | HTY |
| Feb 6, 2015 | K143618 | Kirschner Wires, Steinmann Pins Zimmer, Inc. | HTY |
| Jan 27, 2015 | K143063 | Stryker SonicPin System, Stryker SonicAnchor System Stryker Trauma GmbH | HTY |
| Oct 24, 2014 | K141714 | PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM Wrightmedicaltechnologyinc | HTY |
| Sep 12, 2014 | K142134 | C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES Conmed Corporation, Largo | HTY |
| Aug 21, 2014 | K141004 | INTRAOSSEOUS FIXATION SYSTEM Orthohelix Surgical Designs, Inc. | HTY |
| Jul 18, 2014 | K141577 | ARTHREX PIP DART Arthrex, Inc. | HTY |
| Apr 11, 2014 | K133932 | INION FREEDOMPIN Inion OY, FI | HTY |
| Feb 10, 2014 | K133477 | TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS Synchro Medical | HTY |
| Jan 22, 2014 | K133950 | ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) Bioretec, Ltd., FI | HTY |
| Jan 9, 2014 | K133520 | HAMMERLOCK 2 Biomedical Enterprises, Inc. | HTY |
| Oct 23, 2013 | K132895 | WMT IMPLANTABLE K-WIRE Wrightmedicaltechnologyinc | HTY |
| Oct 16, 2013 | K131640 | SMOOTH OR THREADED METALLIC BONE FASTENER Biomedical Ent., Inc. | HTY |
| May 17, 2013 | K130105 | RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM Depuy Mitek, A Johnson & Johnson Company | HTY |
| Mar 15, 2013 | K122415 | X-FIX DYNAMIC EXTERNAL DISTRACTOR Arex USA, LLC | HTY |
| Jun 4, 2012 | K121008 | TRILLIANT SURGICAL K-WIRES Trilliant Surgical, Ltd. | HTY |
| Apr 24, 2012 | K121004 | APEX KIRSCHNER WIRES AND STEINMANN PINS Apex Tools & Orthopedics Co. | HTY |
| Apr 17, 2012 | K120165 | INTRAOSSEOUS FIXATION SYSTEM Orthohelix Surgical Designs, Inc. | HTY |
| Mar 20, 2012 | K103623 | NEWDEAL INTERPHALANGEAL IMPLANT Newdeal Sas, FR | HTY |
| Dec 19, 2011 | K112990 | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE Arthrex, Inc. | HTY |
| Dec 12, 2011 | K112675 | ARROW-LOK DIGITAL SYSTEM Arrowhead Medical Device Technologies, LLC | HTY |
| Nov 17, 2011 | K112197 | MEMOMETAL INTRA-MEDULLARY BONE FASTENER Memometal Technologies, FR | HTY |
| Oct 11, 2011 | K112254 | APEX KIRSCHNER WIRES AND STEINMANN PINS Apex Tools & Orthopedics Co., CN | HTY |
| Apr 28, 2011 | K110123 | PCL TIGHTROPE Arthrex, Inc. | HTY |
| Feb 28, 2011 | K110047 | VERTICOR K-WIRE SYSTEM Verticor, Ltd. | HTY |
| Dec 28, 2010 | K101837 | ACL TIGHTROPE DOUBLE BUNDLE Arthrex, Inc. | HTY |
| Nov 9, 2010 | K102215 | KIRSCHNER WIRES, STEINMAN PINS Evergreen Orthopedic Research Lab | HTY |
| Nov 3, 2010 | K102072 | MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) Memometal Technologies, FR | HTY |
| Oct 29, 2010 | K100926 | ARROWHEAD FIXATION DEVICE Arrow Products, Inc. | HTY |
| Sep 10, 2010 | K100736 | KIRSCHNER AND GUIDE WIRES Smt Schilling Metalltechnik GmbH, DE | HTY |
| Aug 17, 2010 | K094043 | LIGAMENTOTAXOR Arex USA | HTY |
| Jun 23, 2010 | K100652 | ACL TIGHTROPE Arthrex, Inc. | HTY |
| Apr 2, 2010 | K091955 | STRYKER SONICPIN SYSTEM Howmedica Osteonics Corp. | HTY |
| Feb 19, 2010 | K091951 | HAMMERLOCK Biomedical Ent., Inc. | HTY |
| Sep 23, 2009 | K092038 | APTUS K-WIRE SYSTEM Medartis AG | HTY |
| Mar 18, 2009 | K083490 | BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 Biopro, Inc. | HTY |
| Oct 17, 2008 | K082375 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM OrthoPediatrics Corp. | HTY |
| Oct 10, 2008 | K082017 | STARR FRAME STEINMANN PIN Starr Frame, LLC | HTY |
| Jun 24, 2008 | K080879 | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM Bioretec, Ltd., FI | HTY |
| Jun 3, 2008 | K081097 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM Orthopediatrics, LLC | HTY |
| May 13, 2008 | K073311 | OSTEOTRANS-OT PIN Takiron Co., Ltd., JP | HTY |
| Mar 24, 2008 | K073674 | BONE FIXATION WIRE (KIRSCHNER WIRE) Signal Medical Corp. | HTY |
| Dec 19, 2007 | K071616 | ARC SURGICAL BIOTRAK PIN SYSTEM Arc Surgical, LLC | HTY |
| Aug 31, 2007 | K071863 | ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) Bioretec, Ltd., FI | HTY |
| Jul 26, 2007 | K070598 | MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE Memometal Technologies, FR | HTY |
| Jul 13, 2007 | K070555 | ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES Orthopro, LLC | HTY |
| May 25, 2007 | K070561 | KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES Teleflex Medical | HTY |
| Mar 6, 2007 | K063719 | ARTHREX CROSSPIN, MODEL AR-1964P Arthrex, Inc. | HTY |
| Jul 18, 2006 | K061607 | STORM OPERATING KIT, MODEL 1-10-0 Intelligent Orthopaedics, Ltd., GB | HTY |
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