Panels › Orthopedic › Product code PLF · Class 2
Bone Wedge
Regulation 888.3030
1510(k)s in 12 months (18 all time)
2recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in PLF
| Company | 510(k)s | Recalls |
|---|---|---|
| Nvision Biomedical Technologies | 7 | 0 |
| Arthrex, Inc. | 0 | 6 |
| Paragon 28 | 2 | 3 |
| Tyber Medical, LLC | 2 | 0 |
| Additive Device, Inc. (Adi) D/B/A Restor3D | 1 | 0 |
| Ames Medical Prosthetic Solutions, S.A.U. | 1 | 0 |
| Arthex, Inc. | 1 | 0 |
| Auxano Medical, LLC | 1 | 0 |
| MiRus, LLC | 1 | 0 |
| Restor3D, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 19, 2026 | K252733 | ATLAS Expandable Osteotomy Wedge System MiRus, LLC | PLF |
| Oct 17, 2025 | K252254 | Osteotomy Wedge System Sinaptic Surgical | PLF |
| Sep 25, 2025 | K251791 | Auxano® Wedge Fixation System Auxano Medical, LLC | PLF |
| Dec 6, 2024 | K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories Ames Medical Prosthetic Solutions, S.A.U., ES | PLF |
| Nov 8, 2024 | K243231 | Trigon PEEK HA Wedges Nvision Biomedical Technologies | PLF |
| Jan 26, 2024 | K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System Nvision Biomedical Technologies | PLF |
| Aug 22, 2023 | K231496 | TITAN 3-D Wedge System Paragon 28, Inc. | PLF |
| Dec 1, 2022 | K223226 | Trigon HA Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Feb 23, 2022 | K220197 | Trigon HA Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Jun 17, 2021 | K201314 | Restor3d Utility Wedge Restor3D, Inc. | PLF |
| Dec 21, 2020 | K203445 | Trigon HA Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Feb 25, 2020 | K193414 | Trigon HA Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Dec 23, 2019 | K192645 | Trigon Ti Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Nov 5, 2019 | K191047 | ADI TiDAL Osteotomy Wedge Additive Device, Inc. (Adi) D/B/A Restor3D | PLF |
| May 16, 2017 | K171327 | Tyber Medical Wedge System Tyber Medical, LLC | PLF |
| Apr 3, 2017 | K162241 | TITAN 3-D Wedge System Paragon 28 | PLF |
| Aug 12, 2015 | K151256 | Arthrex BioSync® Bone Wedge Arthex, Inc. | PLF |
| Jul 28, 2015 | K150394 | Tyber Medical Wedge System Tyber Medical, LLC | PLF |
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