Product code HTY
- Device name
- Pin, Fixation, Smooth
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3040
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | 2025-12-29 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| K250315 | RONAVIS – FX (FX-001) | AIRS, Inc. | 2025-08-01 |
| K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | 2025-06-24 |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025-06-11 |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | 2024-05-22 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | 2023-12-01 |
| K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023-09-14 |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | 2023-09-13 |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023-08-14 |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | 2023-07-06 |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022-09-06 |
| K220906 | SECURE-LOCK | Xiros, Ltd. | 2022-07-22 |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | 2022-02-17 |
| K211789 | restor3d Pin Implants | Restor3D | 2022-01-04 |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | 2021-09-30 |
| K203698 | CoLink Sfx Implant System | In2bones USA, LLC | 2021-05-04 |
| K203475 | LimaCorporate Kirschner Wire | Lima Corporate S.P.A. | 2021-02-05 |
| K201838 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | 2021-01-29 |
| K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design | OSSIO , Ltd. | 2021-01-06 |
| K202777 | VeriFixx™ Small Bone Implant | Armis Biopharma, Inc. | 2020-11-17 |
| K201803 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant | OSSIO , Ltd. | 2020-10-16 |
| K201715 | Smart Toe II, X Fuse | Stryker GmbH | 2020-08-05 |
| K200068 | Arthrex DynaNite K-Wire | Arthrex, Inc. | 2020-06-29 |
| K190652 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant | OSSIO , Ltd. | 2020-03-06 |
| K190926 | Hammertoe Truss System (HTS) | 4Web, Inc. | 2019-07-23 |
| K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex, Inc. | 2019-05-03 |
| K183228 | HammerToe Compression System | Paragon 28, Inc. | 2019-01-25 |
| K181180 | OSSIO™ Pin Product Family | OSSIO , Ltd. | 2019-01-10 |
| K180087 | A.M. Surgical Intramedullary Fixation Device | A.M. Surgical, Inc. | 2018-05-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630894830839 | APTUS | Medartis AG | 2026-06-01 |
| 07630894830884 | APTUS | Medartis AG | 2026-06-01 |
| 07630894830891 | APTUS | Medartis AG | 2026-06-01 |
| 07630894830822 | APTUS | Medartis AG | 2026-06-01 |
| 07630037863977 | APTUS | Medartis AG | 2025-07-31 |
| 07630037863984 | APTUS | Medartis AG | 2025-07-31 |
| 07613327084191 | STEINMANN | Stryker GmbH | 2025-01-09 |
| 09353903030003 | Griplasty System | FIELD ORTHOPAEDICS PTY LTD | 2024-09-19 |
| 07630037863915 | APTUS | Medartis AG | 2024-03-22 |
| 07630037863854 | APTUS | Medartis AG | 2024-03-22 |
| 07613154711246 | NA | Stryker GmbH | 2023-08-14 |
| 07630037863991 | APTUS | Medartis AG | 2023-02-24 |
| 07630037863953 | APTUS | Medartis AG | 2023-02-24 |
| 07630037863922 | APTUS | Medartis AG | 2023-02-24 |
| 07630037863892 | APTUS | Medartis AG | 2023-02-24 |
| 07630037863878 | APTUS | Medartis AG | 2023-02-24 |
| 07630037863861 | APTUS | Medartis AG | 2023-02-24 |
| 07630037863830 | APTUS | Medartis AG | 2023-02-24 |
| 07630037863816 | APTUS | Medartis AG | 2023-02-24 |
| 07630037863809 | APTUS | Medartis AG | 2023-02-24 |
| 07630037863779 | APTUS | Medartis AG | 2023-02-24 |
| 07630008402891 | APTUS | Medartis AG | 2021-06-17 |
| 07630037836711 | APTUS | Medartis AG | 2020-11-14 |
| 07630037836681 | APTUS | Medartis AG | 2020-11-14 |
| 07630037836650 | APTUS | Medartis AG | 2020-11-14 |
| 07630037836629 | APTUS | Medartis AG | 2020-11-14 |
| 07630008470937 | APTUS | Medartis AG | 2015-10-24 |
| 07613327096156 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096132 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096118 | SonicAnchor | Stryker GmbH | 2015-09-24 |