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 1318)
Showing 20 most recent of 1318 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | Jul 16, 2026 | SESE |
| K261191 | Alians Elbow S | Newclip Technics | Jul 8, 2026 | SESE |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | Jul 1, 2026 | SESE |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | Jun 26, 2026 | SESE |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | Jun 16, 2026 | SESE |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | Jun 12, 2026 | SESE |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | Jun 5, 2026 | SESE |
| K261002 | Pectus Blu System | Biomet Microfixation | Jun 2, 2026 | SESE |
| K261038 | Xpert PFP | Newclip Technics | May 29, 2026 | SESE |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | May 9, 2026 | SESE |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | Apr 30, 2026 | SESE |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | Apr 24, 2026 | SESE |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | Apr 24, 2026 | SESE |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | Apr 24, 2026 | SESE |
| 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 |
Top Applicants
- Synthes (Usa) — 87 clearances
- Wrightmedicaltechnologyinc — 45 clearances
- Arthrex, Inc. — 39 clearances
- Smith & Nephew, Inc. — 34 clearances
- Medartis AG — 31 clearances
