PLF · Bone Wedge
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | PLF |
|---|---|
| Device Name | Bone Wedge |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification Rationale
Class II.
Cleared Devices (18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252733 | ATLAS Expandable Osteotomy Wedge System | MiRus, LLC | Feb 19, 2026 | SESE |
| K252254 | Osteotomy Wedge System | Sinaptic Surgical | Oct 17, 2025 | SESE |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | Sep 25, 2025 | SESE |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | Dec 6, 2024 | SESE |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | Nov 8, 2024 | SESE |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | Jan 26, 2024 | SESE |
| K231496 | TITAN 3-D Wedge System | Paragon 28, Inc. | Aug 22, 2023 | SESE |
| K223226 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | Dec 1, 2022 | SESE |
| K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | Feb 23, 2022 | SESE |
| K201314 | Restor3d Utility Wedge | Restor3D, Inc. | Jun 17, 2021 | SESE |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | Dec 21, 2020 | SESE |
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | Feb 25, 2020 | SESE |
| K192645 | Trigon Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | Dec 23, 2019 | SESE |
| K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | Nov 5, 2019 | SESE |
| K171327 | Tyber Medical Wedge System | Tyber Medical, LLC | May 16, 2017 | SESE |
| K162241 | TITAN 3-D Wedge System | Paragon 28 | Apr 3, 2017 | SESE |
| K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | Aug 12, 2015 | SESE |
| K150394 | Tyber Medical Wedge System | Tyber Medical, LLC | Jul 28, 2015 | SESE |
Top Applicants
- Nvision Biomedical Technologies, Inc. — 5 clearances
- Tyber Medical, LLC — 2 clearances
- Nvision Biomedical Technologies — 2 clearances
- Sinaptic Surgical — 1 clearance
- Restor3D, Inc. — 1 clearance
