PLF
- Product code
- PLF
- Device name
- Bone Wedge
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 18
FDA classification definition
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252733 | 2026-02-19 | MiRus, LLC | ATLAS Expandable Osteotomy Wedge System | |
| K252254 | 2025-10-17 | Sinaptic Surgical | Osteotomy Wedge System | |
| K251791 | 2025-09-25 | Auxano Medical, LLC | Auxano® Wedge Fixation System | |
| K240461 | 2024-12-06 | Ames Medical Prosthetic Solutions, S.A | OsteoSinter® EVANS and COTTON wedges and related acc | |
| K243231 | 2024-11-08 | Nvision Biomedical Technologies | Trigon PEEK HA Wedges | |
| K234116 | 2024-01-26 | Nvision Biomedical Technologies | Trigon Trigon HA Stand-Alone Wedge Fixation System |
Official FDA classification page: PLF
Classification and pathway per current FDA publications. Data from openFDA (CC0).