PLF — Bone Wedge Class II
FDA product code PLF covers "Bone Wedge", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PLF
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252733 | mirus | ATLAS Expandable Osteotomy Wedge System | February 19, 2026 |
| K252254 | sinaptic surgical | Osteotomy Wedge System | October 17, 2025 |
| K251791 | auxano medical | Auxano® Wedge Fixation System | September 25, 2025 |
| K240461 | ames medical prosthetic solutions, s.a.u | OsteoSinter® EVANS and COTTON wedges and related accessories | December 6, 2024 |
| K243231 | nvision biomedical technologies | Trigon PEEK HA Wedges | November 8, 2024 |
| K234116 | nvision biomedical technologies | Trigon Trigon HA Stand-Alone Wedge Fixation System | January 26, 2024 |
| K231496 | paragon 28 | TITAN 3-D Wedge System | August 22, 2023 |
| K223226 | nvision biomedical technologies | Trigon HA Stand-Alone Wedge Fixation System | December 1, 2022 |
| K220197 | nvision biomedical technologies | Trigon HA Wedge Fixation System | February 23, 2022 |
| K201314 | restor3d | Restor3d Utility Wedge | June 17, 2021 |
| K203445 | nvision biomedical technologies | Trigon HA Stand-Alone Wedge Fixation System | December 21, 2020 |
| K193414 | nvision biomedical technologies | Trigon HA Stand-Alone Wedge Fixation System | February 25, 2020 |
| K192645 | nvision biomedical technologies | Trigon Ti Stand-Alone Wedge Fixation System | December 23, 2019 |
| K191047 | additive device, inc. (adi) d/b/a restor3d | ADI TiDAL Osteotomy Wedge | November 5, 2019 |
| K171327 | tyber medical | Tyber Medical Wedge System | May 16, 2017 |
| K162241 | paragon 28 | TITAN 3-D Wedge System | April 3, 2017 |
| K151256 | arthex | Arthrex BioSync® Bone Wedge | August 12, 2015 |
| K150394 | tyber medical | Tyber Medical Wedge System | July 28, 2015 |