Product code HRSClass 2
Plate, Fixation, Bone 510(k) Clearances
Product code HRS is the FDA classification for Plate, Fixation, Bone, a Class 2 device regulated under 21 CFR 888.3030, reviewed by the FDA Orthopedic panel. FDA has cleared 1,311 510(k) submissions under this product code.
Every device cleared under product code HRS shares the same intended use and device type, so they are candidate predicate devices for a new 510(k) of this type. Open any device below to see its full clearance record and its candidate predicates.
- Cleared devices
- 1,311
- Device class
- Class 2
- Regulation
- 888.3030
- Latest clearance
- 2026-06-05
Cleared devices under product code HRS
Showing the 50 most recent of 1,311 cleared devices. Clearances from 2025-08-16 to 2026-06-05.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026-06-05 |
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 |
| K261038 | Xpert PFP | Newclip Technics | 2026-05-29 |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026-05-09 |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026-04-24 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026-04-24 |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | 2026-04-10 |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026-04-01 |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | 2026-03-25 |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026-03-25 |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | 2026-03-24 |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | 2026-03-23 |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026-03-19 |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | 2026-03-17 |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | 2026-03-16 |
| K253906 | Xpert Hand | Newclip Technics | 2026-03-11 |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | Synthes GmbH | 2026-03-09 |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | 2026-03-03 |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | Synthes GmbH | 2026-03-02 |
| K254249 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | 2026-02-27 |
| K252166 | RIB LINK Fixation System | Globus Medical, Inc. | 2026-02-26 |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | 2026-02-20 |
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2026-02-20 |
| K251732 | Wrist Fracture System | Met One Technologies, LLC | 2026-02-12 |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | 2026-01-21 |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) | TriMed, Inc. | 2026-01-15 |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. | 2026-01-12 |
| K253178 | TRILEAP Plating System | Crossroads Extremity Systems | 2026-01-06 |
| K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio | 2025-12-19 |
| K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG | 2025-12-17 |
| K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2025-12-11 |
| K252897 | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista | A Plus Biotechnology Co., Ltd. | 2025-12-11 |
| K252997 | HyperFlex® Bunion Correction System | Hyperflex Medical | 2025-12-11 |
| K252661 | SternaFuse Ti Fixation System | Fusion Innovations, LLC | 2025-11-19 |
| K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2025-11-18 |
| K250865 | KLS Martin IPS Forearm System | KLS-Martin L.P. | 2025-11-14 |
| K252949 | Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. | 2025-11-13 |
| K252959 | WRISTAR MultiAx Distal Radius Kit | Intrauma S.P.A | 2025-11-12 |
| K253300 | Fine Osteotomy | Bodycad Laboratories, Inc. | 2025-10-28 |
| K252600 | Pediatric Plating Platform I Small-Mini | OrthoPediatrics Corp. | 2025-10-09 |
| K251892 | MAXXOS P.A.C.E. Foot & Ankle Plating System | Maxxos Medical GmbH | 2025-09-08 |
| K250923 | Fine Osteotomy | Bodycad Laboratories, Inc. | 2025-08-21 |
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | Acumed, LLC | 2025-08-21 |
| K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025-08-21 |
| K252061 | Distal Xtremities System | TriMed, Inc. | 2025-08-20 |
| K251161 | ANTHEM® Fracture System | Globus Medical, Inc. | 2025-08-18 |
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | OsteoCentric Technologies | 2025-08-16 |
Filing a 510(k) for a Plate, Fixation, Bone of this type?
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