HRS · Plate, Fixation, Bone
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | HRS |
|---|---|
| Device Name | Plate, Fixation, Bone |
| 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.
Recent Cleared Devices (20 of 1303)
Showing 20 most recent of 1303 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | Apr 10, 2026 | SESE |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | Apr 1, 2026 | SESE |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | Mar 25, 2026 | SESE |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | Mar 25, 2026 | SESE |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | Mar 24, 2026 | SESE |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | Mar 23, 2026 | SESE |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | Mar 19, 2026 | SESE |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | Mar 17, 2026 | SESE |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | Mar 17, 2026 | SESE |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | Mar 16, 2026 | SESE |
| K253906 | Xpert Hand | Newclip Technics | Mar 11, 2026 | SESE |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | Synthes GmbH | Mar 9, 2026 | SESE |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | Mar 3, 2026 | SESE |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | Synthes GmbH | Mar 2, 2026 | SESE |
| K254249 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | Feb 27, 2026 | SESE |
| K252166 | RIB LINK Fixation System | Globus Medical, Inc. | Feb 26, 2026 | SESE |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | Feb 20, 2026 | SESE |
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | Feb 20, 2026 | SESE |
| K251732 | Wrist Fracture System | Met One Technologies, LLC | Feb 12, 2026 | SESE |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | Jan 21, 2026 | SESE |
Top Applicants
- Synthes (Usa) — 87 clearances
- Wrightmedicaltechnologyinc — 45 clearances
- Arthrex, Inc. — 39 clearances
- Smith & Nephew, Inc. — 34 clearances
- Medartis AG — 30 clearances
