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 |
|---|---|---|---|
| Oct 22, 2026 | K262126 | Cerclage Wires;K-wires;Steinmann Pins MK Medical GmbH, DE | HTY |
| Aug 28, 2026 | K262722 | Primal K-Wire (P99-193-1410) Paragon 28, Inc. | HTY |
| Dec 29, 2025 | K253325 | ZipToe Hammertoe Fusion System Toetal Solutions | HTY |
| Sep 19, 2025 | K252657 | Impact PEEK Union Nail System Nvision Biomedical Technologies, Inc. | HTY |
| Aug 1, 2025 | K250315 | RONAVIS FX (FX-001) AIRS, Inc., KR | HTY |
| Jun 24, 2025 | K251362 | PediFlex Flexible Nail System OrthoPediatrics Corp. | HTY |
| Jun 11, 2025 | K250646 | Impact PEEK Union Nail System Nvision Biomedical Technologies | HTY |
| May 22, 2024 | K241014 | Biomet Kirschner Wires (K-Wires) Biomet, Inc. | HTY |
| Dec 1, 2023 | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail OSSIO , Ltd., IL | HTY |
| Sep 14, 2023 | K231147 | Hammerdesis Interphalangeal Fusion System Intelivation | HTY |
| Sep 13, 2023 | K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail OSSIO , Ltd., IL | HTY |
| Aug 14, 2023 | K231905 | Electro-Spec Steri-Caps Electro-Spec, Inc. | HTY |
| Jul 6, 2023 | K231339 | Tyber Medical Pin and Wire System (various) Tyber Medical, LLC | HTY |
| Sep 6, 2022 | K221283 | Hammertoe Truss System (HTS) 4Web Medical, Inc. | HTY |
| Jul 22, 2022 | K220906 | SECURE-LOCK Xiros, Ltd., GB | HTY |
| Feb 17, 2022 | K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires Pacific Instruments | HTY |
| Jan 4, 2022 | K211789 | restor3d Pin Implants Restor3D | HTY |
| Sep 30, 2021 | K211439 | Small Bone Nailing System Skeletal Dynamics, Inc. | HTY |
| May 4, 2021 | K203698 | CoLink Sfx Implant System In2bones USA, LLC | HTY |
| Feb 5, 2021 | K203475 | LimaCorporate Kirschner Wire Lima Corporate S.P.A., IT | HTY |
| Jan 29, 2021 | K201838 | PediFlex Flexible Nail System OrthoPediatrics Corp. | HTY |
| Jan 6, 2021 | K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, C OSSIO , Ltd., IL | HTY |
| Nov 17, 2020 | K202777 | VeriFixx Small Bone Implant Armis Biopharma, Inc. | HTY |
| Oct 16, 2020 | K201803 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant OSSIO , Ltd., IL | HTY |
| Aug 5, 2020 | K201715 | Smart Toe II, X Fuse Stryker GmbH | HTY |
| Jun 29, 2020 | K200068 | Arthrex DynaNite K-Wire Arthrex, Inc. | HTY |
| Mar 6, 2020 | K190652 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant OSSIO , Ltd., IL | HTY |
| Jul 23, 2019 | K190926 | Hammertoe Truss System (HTS) 4Web, Inc. | HTY |
| May 3, 2019 | K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant Arthrex, Inc. | HTY |
| Jan 25, 2019 | K183228 | HammerToe Compression System Paragon 28, Inc. | HTY |
| Jan 10, 2019 | K181180 | OSSIO Pin Product Family OSSIO , Ltd., IL | HTY |
| May 18, 2018 | K180087 | A.M. Surgical Intramedullary Fixation Device A.M. Surgical, Inc. | HTY |
| Mar 5, 2018 | K171715 | HammerTube System Paragon 28 | HTY |
| Mar 2, 2018 | K172485 | Footmotion HammerToe Newclip Technics, FR | HTY |
| Jan 19, 2018 | K173616 | DIP Arthrodesis System In2bones Sas, FR | HTY |
| Dec 14, 2017 | K173013 | WishBone K-Wire System Wishbone Medical, Inc. | HTY |
| Nov 16, 2017 | K173051 | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL Orthofix Srl, IT | HTY |
| Jul 20, 2017 | K170326 | dynaMX Intramedullary Implant Arthrex, Inc. | HTY |
| Jun 20, 2017 | K170418 | Stryker SonicPin System Stryker Trauma GmbH, DE | HTY |
| May 8, 2017 | K163327 | Precifit Medical Kirschner Wires Precifit Medical, Ltd. | HTY |
| Sep 16, 2016 | K161489 | Syntorr K-wire and Pin System Syntorr, Inc. | HTY |
| Jun 1, 2016 | K160264 | Additive Orthopaedics Hammertoe Correction System Additive Orthopaedics, LLC | HTY |
| Apr 26, 2016 | K160194 | StarFuse Interphalangeal Pin Phalanx Innovations | HTY |
| Mar 9, 2016 | K152662 | S-Wire Spinal Resources, Inc. | HTY |
| Feb 1, 2016 | K153204 | In2Bones Kirschner wire In2bones Sas, FR | HTY |
| Jan 13, 2016 | K152627 | IFS Fixation Scaffold System Metric Medical Devices, Inc. | HTY |
| Dec 30, 2015 | K151876 | Bio2 Fusion Implant System Bio2 Technologies, Inc. | HTY |
| May 29, 2015 | K142478 | opti-Toe Graham Medical Technologies, LLC (D.B.A.Gramedica) | HTY |
| May 1, 2015 | K150626 | Rush Medullary Pins Zimmer, Inc. | HTY |
| Apr 17, 2015 | K150416 | ProCinch Adjustable Loop Device Stryker Endoscopy | HTY |
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