FDA Product Code
FDA Product Code HTY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 205 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | 2026-08-28 | Special | PDF ↗ |
| K253325 | ZipToe Hammertoe Fusion System | Toetal Solutions | 2025-12-29 | Traditional | PDF ↗ |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 | Special | PDF ↗ |
| K250315 | RONAVIS FX (FX-001) | AIRS, Inc. | 2025-08-01 | Traditional | PDF ↗ |
| K251362 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | 2025-06-24 | Traditional | PDF ↗ |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025-06-11 | Traditional | PDF ↗ |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | 2024-05-22 | Traditional | PDF ↗ |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | 2023-12-01 | Traditional | PDF ↗ |
| K231147 | Hammerdesis Interphalangeal Fusion System | Intelivation | 2023-09-14 | Traditional | PDF ↗ |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | 2023-09-13 | Traditional | PDF ↗ |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023-08-14 | Traditional | PDF ↗ |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | 2023-07-06 | Traditional | PDF ↗ |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022-09-06 | Traditional | PDF ↗ |
| K220906 | SECURE-LOCK | Xiros, Ltd. | 2022-07-22 | Traditional | PDF ↗ |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | 2022-02-17 | Traditional | PDF ↗ |
| K211789 | restor3d Pin Implants | Restor3D | 2022-01-04 | Traditional | PDF ↗ |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | 2021-09-30 | Traditional | PDF ↗ |
| K203698 | CoLink Sfx Implant System | In2bones USA, LLC | 2021-05-04 | Traditional | PDF ↗ |
| K203475 | LimaCorporate Kirschner Wire | Lima Corporate S.P.A. | 2021-02-05 | Traditional | PDF ↗ |
| K201838 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | 2021-01-29 | Traditional | PDF ↗ |
| K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design | OSSIO , Ltd. | 2021-01-06 | Traditional | PDF ↗ |
| K202777 | VeriFixx Small Bone Implant | Armis Biopharma, Inc. | 2020-11-17 | Traditional | PDF ↗ |
| K201803 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant | OSSIO , Ltd. | 2020-10-16 | Traditional | PDF ↗ |
| K201715 | Smart Toe II, X Fuse | Stryker GmbH | 2020-08-05 | Traditional | PDF ↗ |
| K200068 | Arthrex DynaNite K-Wire | Arthrex, Inc. | 2020-06-29 | Traditional | PDF ↗ |
| K190652 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant | OSSIO , Ltd. | 2020-03-06 | Traditional | PDF ↗ |
| K190926 | Hammertoe Truss System (HTS) | 4Web, Inc. | 2019-07-23 | Traditional | PDF ↗ |
| K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex, Inc. | 2019-05-03 | Traditional | PDF ↗ |
| K183228 | HammerToe Compression System | Paragon 28, Inc. | 2019-01-25 | Traditional | PDF ↗ |
| K181180 | OSSIO Pin Product Family | OSSIO , Ltd. | 2019-01-10 | Traditional | PDF ↗ |
| K180087 | A.M. Surgical Intramedullary Fixation Device | A.M. Surgical, Inc. | 2018-05-18 | Traditional | PDF ↗ |
| K171715 | HammerTube System | Paragon 28 | 2018-03-05 | Traditional | PDF ↗ |
| K172485 | Footmotion HammerToe | Newclip Technics | 2018-03-02 | Traditional | PDF ↗ |
| K173616 | DIP Arthrodesis System | In2bones Sas | 2018-01-19 | Traditional | PDF ↗ |
| K173013 | WishBone K-Wire System | Wishbone Medical, Inc. | 2017-12-14 | Traditional | PDF ↗ |
| K173051 | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL | Orthofix Srl | 2017-11-16 | Traditional | PDF ↗ |
| K170326 | dynaMX Intramedullary Implant | Arthrex, Inc. | 2017-07-20 | Traditional | PDF ↗ |
| K170418 | Stryker SonicPin System | Stryker Trauma GmbH | 2017-06-20 | Traditional | PDF ↗ |
| K163327 | Precifit Medical Kirschner Wires | Precifit Medical, Ltd. | 2017-05-08 | Traditional | PDF ↗ |
| K161489 | Syntorr K-wire and Pin System | Syntorr, Inc. | 2016-09-16 | Traditional | PDF ↗ |
| K160264 | Additive Orthopaedics Hammertoe Correction System | Additive Orthopaedics, LLC | 2016-06-01 | Traditional | PDF ↗ |
| K160194 | StarFuse Interphalangeal Pin | Phalanx Innovations | 2016-04-26 | Traditional | PDF ↗ |
| K152662 | S-Wire | Spinal Resources, Inc. | 2016-03-09 | Traditional | PDF ↗ |
| K153204 | In2Bones Kirschner wire | In2bones Sas | 2016-02-01 | Traditional | PDF ↗ |
| K152627 | IFS Fixation Scaffold System | Metric Medical Devices, Inc. | 2016-01-13 | Traditional | PDF ↗ |
| K151876 | Bio2 Fusion Implant System | Bio2 Technologies, Inc. | 2015-12-30 | Traditional | PDF ↗ |
| K142478 | opti-Toe | Graham Medical Technologies, LLC (D.B.A.Gramedica) | 2015-05-29 | Traditional | PDF ↗ |
| K150626 | Rush Medullary Pins | Zimmer, Inc. | 2015-05-01 | Traditional | PDF ↗ |
| K150416 | ProCinch Adjustable Loop Device | Stryker Endoscopy | 2015-04-17 | Traditional | PDF ↗ |
| K143702 | Arthrex Blunt Tip Screws with Fiber Tape | Arthrex, Inc. | 2015-04-09 | Traditional | PDF ↗ |
| K143049 | LYNC intramedullary implant | Novastep | 2015-02-19 | Traditional | PDF ↗ |
| K143618 | Kirschner Wires, Steinmann Pins | Zimmer, Inc. | 2015-02-06 | Traditional | PDF ↗ |
| K143063 | Stryker SonicPin System, Stryker SonicAnchor System | Stryker Trauma GmbH | 2015-01-27 | Traditional | PDF ↗ |
| K141714 | PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM | Wrightmedicaltechnologyinc | 2014-10-24 | Traditional | PDF ↗ |
| K142134 | C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES | Conmed Corporation, Largo | 2014-09-12 | Traditional | PDF ↗ |
| K141004 | INTRAOSSEOUS FIXATION SYSTEM | Orthohelix Surgical Designs, Inc. | 2014-08-21 | Special | PDF ↗ |
| K141577 | ARTHREX PIP DART | Arthrex, Inc. | 2014-07-18 | Special | PDF ↗ |
| K133932 | INION FREEDOMPIN | Inion OY | 2014-04-11 | Traditional | PDF ↗ |
| K133477 | TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS | Synchro Medical | 2014-02-10 | Traditional | PDF ↗ |
| K133950 | ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) | Bioretec, Ltd. | 2014-01-22 | Special | PDF ↗ |
| K133520 | HAMMERLOCK 2 | Biomedical Enterprises, Inc. | 2014-01-09 | Traditional | PDF ↗ |
| K132895 | WMT IMPLANTABLE K-WIRE | Wrightmedicaltechnologyinc | 2013-10-23 | Traditional | PDF ↗ |
| K131640 | SMOOTH OR THREADED METALLIC BONE FASTENER | Biomedical Ent., Inc. | 2013-10-16 | Traditional | PDF ↗ |
| K130105 | RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM | Depuy Mitek, A Johnson & Johnson Company | 2013-05-17 | Traditional | PDF ↗ |
| K122415 | X-FIX DYNAMIC EXTERNAL DISTRACTOR | Arex USA, LLC | 2013-03-15 | Traditional | PDF ↗ |
| K121008 | TRILLIANT SURGICAL K-WIRES | Trilliant Surgical, Ltd. | 2012-06-04 | Traditional | PDF ↗ |
| K121004 | APEX KIRSCHNER WIRES AND STEINMANN PINS | Apex Tools & Orthopedics Co. | 2012-04-24 | Special | PDF ↗ |
| K120165 | INTRAOSSEOUS FIXATION SYSTEM | Orthohelix Surgical Designs, Inc. | 2012-04-17 | Traditional | PDF ↗ |
| K103623 | NEWDEAL INTERPHALANGEAL IMPLANT | Newdeal Sas | 2012-03-20 | Traditional | PDF ↗ |
| K112990 | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE | Arthrex, Inc. | 2011-12-19 | Traditional | PDF ↗ |
| K112675 | ARROW-LOK DIGITAL SYSTEM | Arrowhead Medical Device Technologies, LLC | 2011-12-12 | Traditional | PDF ↗ |
| K112197 | MEMOMETAL INTRA-MEDULLARY BONE FASTENER | Memometal Technologies | 2011-11-17 | Special | PDF ↗ |
| K112254 | APEX KIRSCHNER WIRES AND STEINMANN PINS | Apex Tools & Orthopedics Co. | 2011-10-11 | Traditional | PDF ↗ |
| K110123 | PCL TIGHTROPE | Arthrex, Inc. | 2011-04-28 | Traditional | PDF ↗ |
| K110047 | VERTICOR K-WIRE SYSTEM | Verticor, Ltd. | 2011-02-28 | Traditional | PDF ↗ |
| K101837 | ACL TIGHTROPE DOUBLE BUNDLE | Arthrex, Inc. | 2010-12-28 | Traditional | PDF ↗ |
| K102215 | KIRSCHNER WIRES, STEINMAN PINS | Evergreen Orthopedic Research Lab | 2010-11-09 | Traditional | PDF ↗ |
| K102072 | MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) | Memometal Technologies | 2010-11-03 | Traditional | PDF ↗ |
| K100926 | ARROWHEAD FIXATION DEVICE | Arrow Products, Inc. | 2010-10-29 | Traditional | PDF ↗ |
| K100736 | KIRSCHNER AND GUIDE WIRES | Smt Schilling Metalltechnik GmbH | 2010-09-10 | Traditional | PDF ↗ |
| K094043 | LIGAMENTOTAXOR | Arex USA | 2010-08-17 | Traditional | PDF ↗ |
| K100652 | ACL TIGHTROPE | Arthrex, Inc. | 2010-06-23 | Special | PDF ↗ |
| K091955 | STRYKER SONICPIN SYSTEM | Howmedica Osteonics Corp. | 2010-04-02 | Traditional | PDF ↗ |
| K091951 | HAMMERLOCK | Biomedical Ent., Inc. | 2010-02-19 | Traditional | PDF ↗ |
| K092038 | APTUS K-WIRE SYSTEM | Medartis AG | 2009-09-23 | Traditional | PDF ↗ |
| K083490 | BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 | Biopro, Inc. | 2009-03-18 | Traditional | PDF ↗ |
| K082375 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | OrthoPediatrics Corp. | 2008-10-17 | Traditional | PDF ↗ |
| K082017 | STARR FRAME STEINMANN PIN | Starr Frame, LLC | 2008-10-10 | Abbreviated | PDF ↗ |
| K080879 | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM | Bioretec, Ltd. | 2008-06-24 | Traditional | PDF ↗ |
| K081097 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | Orthopediatrics, LLC | 2008-06-03 | Traditional | PDF ↗ |
| K073311 | OSTEOTRANS-OT PIN | Takiron Co., Ltd. | 2008-05-13 | Traditional | PDF ↗ |
| K073674 | BONE FIXATION WIRE (KIRSCHNER WIRE) | Signal Medical Corp. | 2008-03-24 | Traditional | PDF ↗ |
| K071616 | ARC SURGICAL BIOTRAK PIN SYSTEM | Arc Surgical, LLC | 2007-12-19 | Traditional | PDF ↗ |
| K071863 | ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) | Bioretec, Ltd. | 2007-08-31 | Special | PDF ↗ |
| K070598 | MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE | Memometal Technologies | 2007-07-26 | Traditional | PDF ↗ |
| K070555 | ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES | Orthopro, LLC | 2007-07-13 | Traditional | PDF ↗ |
| K070561 | KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES | Teleflex Medical | 2007-05-25 | Abbreviated | PDF ↗ |
| K063719 | ARTHREX CROSSPIN, MODEL AR-1964P | Arthrex, Inc. | 2007-03-06 | Traditional | PDF ↗ |
| K061607 | STORM OPERATING KIT, MODEL 1-10-0 | Intelligent Orthopaedics, Ltd. | 2006-07-18 | Traditional | PDF ↗ |
| K061164 | ACTIVAPIN | Bioretec, Ltd. | 2006-07-06 | Traditional | PDF ↗ |
Product code HTY · Class II · Orthopedic. Data: openFDA.