Product code PLF
- Device name
- Bone Wedge
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | 2026-02-19 |
| K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025-10-17 |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | 2025-09-25 |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | 2024-12-06 |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024-11-08 |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024-01-26 |
| K231496 | TITAN 3-D Wedge System | Paragon 28, Inc. | 2023-08-22 |
| K223226 | Trigon™ HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-12-01 |
| K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-02-23 |
| K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021-06-17 |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-12-21 |
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-02-25 |
| K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019-12-23 |
| K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019-11-05 |
| K171327 | Tyber Medical Wedge System | Tyber Medical, LLC | 2017-05-16 |
| K162241 | TITAN 3-D™ Wedge System | Paragon 28 | 2017-04-03 |
| K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | 2015-08-12 |
| K150394 | Tyber Medical Wedge System | Tyber Medical, LLC | 2015-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G81711325121606 | SiNAPTIC Osteotomy Wedge System | SINTX Technologies, Inc. | 2026-04-06 |
| G81711325121605 | SiNAPTIC Osteotomy Wedge System | SINTX Technologies, Inc. | 2026-04-06 |
| G817103151200 | SiNAPTIC Osteotomy Wedge System | SINTX Technologies, Inc. | 2026-04-06 |
| G817103151100 | SiNAPTIC Osteotomy Wedge System | SINTX Technologies, Inc. | 2026-04-06 |
| 07630037866596 | APTUS | Medartis AG | 2023-02-24 |
| 07630037866558 | APTUS | Medartis AG | 2023-02-24 |
| 07630037866510 | APTUS | Medartis AG | 2023-02-24 |
| 07630037866473 | APTUS | Medartis AG | 2023-02-24 |
| 07630037866459 | APTUS | Medartis AG | 2023-02-24 |
| 07630037866411 | APTUS | Medartis AG | 2023-02-24 |
| 00888867202733 | Arthrex® | ARTHREX, INC. | 2017-02-25 |
| 00888867202856 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202870 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202863 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202702 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202849 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202832 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202825 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202818 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202801 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202795 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202788 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202771 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202764 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202757 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202740 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202726 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867202719 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867266780 | Arthrex® | ARTHREX, INC. | 2017-01-16 |
| 00888867266803 | Arthrex® | ARTHREX, INC. | 2017-01-16 |