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 1,319 510(k) submissions under this product code.
Devices under product code HRSshare an FDA classification category, but product-code overlap does not establish the same intended use, technological characteristics, or legal predicate eligibility. Treat this list as a screening cohort and review each device's indications, labeling, substantial-equivalence summary, and current legal-marketing status.
- Cleared devices
- 1,319
- Device class
- Class 2
- Regulation
- 888.3030
- Latest clearance
Cleared devices under product code HRS
Showing the 50 most recent of 1,319 cleared devices. Clearances from 2025-10-28 to 2026-07-21.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | |
| 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. | |
| K261191 | Alians Elbow S | Newclip Technics | |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | |
| 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 | |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | |
| K261002 | Pectus Blu System | Biomet Microfixation | |
| K261038 | Xpert PFP | Newclip Technics | |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | |
| K253906 | Xpert Hand | Newclip Technics | |
| K254093 | DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System | Synthes GmbH | |
| K260069 | DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System | Synthes GmbH | |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | |
| K254054 | VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System | Synthes GmbH | |
| K254249 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | |
| K252166 | RIB LINK™ Fixation System | Globus Medical, Inc. | |
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | |
| K251732 | Wrist Fracture System | Met One Technologies, LLC | |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | |
| 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. | |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. | |
| K253178 | TRILEAP Plating System | Crossroads Extremity Systems | |
| K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio | |
| K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG | |
| K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | |
| 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. | |
| K252997 | HyperFlex® Bunion Correction System | Hyperflex Medical | |
| K252661 | SternaFuse Ti Fixation System | Fusion Innovations, LLC | |
| K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. | |
| K250865 | KLS Martin IPS Forearm System | KLS-Martin L.P. | |
| K252949 | Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. | |
| K252959 | WRISTAR MultiAx Distal Radius Kit | Intrauma S.P.A | |
| K253300 | Fine Osteotomy™ | Bodycad Laboratories, Inc. |
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