Bone Wedge
The Bone Wedge (product code PLF) is a Class 2 orthopedic implant intended for use with ancillary fixation in opening wedge osteotomies or fusion procedures in the ankle, foot, or proximal tibia, regulated under 888.3030. It requires 510(k) clearance and is flagged as an implant device. The device is not classified as life-sustaining.
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Basic Information
- Product Code
- PLF
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252733 | ATLAS Expandable Osteotomy Wedge System | Feb 19, 2026 | Substantially Equivalent | MiRus, LLC |
| K252254 | Osteotomy Wedge System | Oct 17, 2025 | Substantially Equivalent | Sinaptic Surgical |
| K251791 | Auxano® Wedge Fixation System | Sep 25, 2025 | Substantially Equivalent | Auxano Medical, LLC |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Dec 06, 2024 | Substantially Equivalent | Ames Medical Prosthetic Solutions, S.A.U. |
| K243231 | Trigon PEEK HA Wedges | Nov 08, 2024 | Substantially Equivalent | Nvision Biomedical Technologies |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Jan 26, 2024 | Substantially Equivalent | Nvision Biomedical Technologies |
| K231496 | TITAN 3-D Wedge System | Aug 22, 2023 | Substantially Equivalent | Paragon 28, Inc. |
| K223226 | Trigon HA Stand-Alone Wedge Fixation System | Dec 01, 2022 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K220197 | Trigon HA Wedge Fixation System | Feb 23, 2022 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K201314 | Restor3d Utility Wedge | Jun 17, 2021 | Substantially Equivalent | Restor3D, Inc. |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Dec 21, 2020 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | Feb 25, 2020 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K192645 | Trigon Ti Stand-Alone Wedge Fixation System | Dec 23, 2019 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K191047 | ADI TiDAL Osteotomy Wedge | Nov 05, 2019 | Substantially Equivalent | Additive Device, Inc. (Adi) D/B/A Restor3D |
| K171327 | Tyber Medical Wedge System | May 16, 2017 | Substantially Equivalent | Tyber Medical, LLC |
| K162241 | TITAN 3-D Wedge System | Apr 03, 2017 | Substantially Equivalent | Paragon 28 |
| K151256 | Arthrex BioSync® Bone Wedge | Aug 12, 2015 | Substantially Equivalent | Arthex, Inc. |
| K150394 | Tyber Medical Wedge System | Jul 28, 2015 | Substantially Equivalent | Tyber Medical, LLC |
FEI Numbers
This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.