Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HTY — Predicate Candidate Screening
204 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
233 days90th percentile
204clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | 2025-12-29 | 90 | 0 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 | 28 | 0 |
| K250315 | RONAVIS – FX (FX-001) | AIRS, Inc. | 2025-08-01 | 178 | 0 |
| K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | 2025-06-24 | 54 | 0 |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025-06-11 | 99 | 0 |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | 2024-05-22 | 40 | 0 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Scre | OSSIO , Ltd. | 2023-12-01 | 213 | 0 |
| K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023-09-14 | 146 | 0 |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | 2023-09-13 | 180 | 0 |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023-08-14 | 46 | 0 |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | 2023-07-06 | 59 | 0 |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022-09-06 | 126 | 0 |
| K220906 | SECURE-LOCK | Xiros, Ltd. | 2022-07-22 | 115 | 0 |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kir | Pacific Instruments | 2022-02-17 | 59 | 0 |
| K211789 | restor3d Pin Implants | Restor3D | 2022-01-04 | 208 | 0 |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | 2021-09-30 | 143 | 0 |
| K203698 | CoLink Sfx Implant System | In2bones USA, LLC | 2021-05-04 | 137 | 0 |
| K203475 | LimaCorporate Kirschner Wire | Lima Corporate S.P.A. | 2021-02-05 | 72 | 0 |
| K201838 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | 2021-01-29 | 211 | 0 |
| K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Tr | OSSIO , Ltd. | 2021-01-06 | 43 | 0 |
| K202777 | VeriFixx™ Small Bone Implant | Armis Biopharma, Inc. | 2020-11-17 | 56 | 0 |
| K201803 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe | OSSIO , Ltd. | 2020-10-16 | 108 | 0 |
| K201715 | Smart Toe II, X Fuse | Stryker GmbH | 2020-08-05 | 43 | 0 |
| K200068 | Arthrex DynaNite K-Wire | Arthrex, Inc. | 2020-06-29 | 168 | 0 |
| K190652 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe | OSSIO , Ltd. | 2020-03-06 | 359 | 0 |
| K190926 | Hammertoe Truss System (HTS) | 4Web, Inc. | 2019-07-23 | 105 | 0 |
| K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex, Inc. | 2019-05-03 | 81 | 0 |
| K183228 | HammerToe Compression System | Paragon 28, Inc. | 2019-01-25 | 66 | 0 |
| K181180 | OSSIO™ Pin Product Family | OSSIO , Ltd. | 2019-01-10 | 253 | 0 |
| K180087 | A.M. Surgical Intramedullary Fixation Device | A.M. Surgical, Inc. | 2018-05-18 | 126 | 0 |
| K171715 | HammerTube System | Paragon 28 | 2018-03-05 | 269 | 0 |
| K172485 | Footmotion HammerToe | Newclip Technics | 2018-03-02 | 197 | 0 |
| K173616 | DIP Arthrodesis System | In2bones Sas | 2018-01-19 | 58 | 0 |
| K173013 | WishBone K-Wire System | Wishbone Medical, Inc. | 2017-12-14 | 78 | 0 |
| K173051 | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL | Orthofix Srl | 2017-11-16 | 49 | 0 |
| K170326 | dynaMX Intramedullary Implant | Arthrex, Inc. | 2017-07-20 | 168 | 0 |
| K170418 | Stryker SonicPin System | Stryker Trauma GmbH | 2017-06-20 | 127 | 0 |
| K163327 | Precifit Medical Kirschner Wires | Precifit Medical, Ltd. | 2017-05-08 | 161 | 0 |
| K161489 | Syntorr K-wire and Pin System | Syntorr, Inc. | 2016-09-16 | 107 | 0 |
| K160264 | Additive Orthopaedics Hammertoe Correction System | Additive Orthopaedics, LLC | 2016-06-01 | 120 | 0 |
| K160194 | StarFuse Interphalangeal Pin | Phalanx Innovations | 2016-04-26 | 90 | 0 |
| K152662 | S-Wire | Spinal Resources, Inc. | 2016-03-09 | 174 | 0 |
| K153204 | In2Bones Kirschner wire | In2bones Sas | 2016-02-01 | 89 | 0 |
| K152627 | IFS Fixation Scaffold System | Metric Medical Devices, Inc. | 2016-01-13 | 120 | 0 |
| K151876 | Bio2 Fusion Implant System | Bio2 Technologies, Inc. | 2015-12-30 | 174 | 0 |
| K142478 | opti-Toe | Graham Medical Technologies, LLC (D.B.A.Gramedica) | 2015-05-29 | 268 | 0 |
| K150626 | Rush Medullary Pins | Zimmer, Inc. | 2015-05-01 | 51 | 0 |
| K150416 | ProCinch Adjustable Loop Device | Stryker Endoscopy | 2015-04-17 | 58 | 0 |
| K143702 | Arthrex Blunt Tip Screws with Fiber Tape | Arthrex, Inc. | 2015-04-09 | 106 | 0 |
| K143049 | LYNC intramedullary implant | Novastep | 2015-02-19 | 119 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda