HRS
- Product code
- HRS
- Device name
- Plate, Fixation, Bone
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 161
- Summaries archived here
- 147 (direct download)
- 510(k) clearances (all years, FDA)
- 1323 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (161)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261830 | 2026-08-28 | Ortler Global Tibbi Gerecler Anonim Si… | FRAXION 3.5 Plate System (Various - See Catalog);FRA… | |
| K262537 | 2026-08-19 | GM Dos Reis Industria e Comercio Ltda. | Versalock Sterile Plating System | |
| K260277 | 2026-08-13 | Mikron Makina San. ve Tic. Ltd. Sti. | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | |
| K261511 | 2026-07-28 | Newclip Technics | Xpert Ankle | |
| K261406 | 2026-07-21 | GM Dos Reis Industria e Comercio Ltda. | Versalock Proximal Tibial Plating System | |
| K262032 | 2026-07-16 | TriMed, Inc. | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);T… | |
| K261191 | 2026-07-08 | Newclip Technics | Alians Elbow S | |
| K261054 | 2026-07-01 | Stryker Leibinger GmbH & Co KG | RibPlate System | |
| K261351 | 2026-06-26 | Bonebridge AG | SALGINA 2.5mm Distal Radius System | |
| K260958 | 2026-06-16 | I.T.S. GmbH | I.T.S. Clavicle Plates with Angular Stability; I.T.S… | FDA |
| K261207 | 2026-06-12 | Tyber Medical, LLC | Exalta Proximal Tibia Plating System | |
| K260761 | 2026-06-05 | Medartis AG | APTUS Clavicle System 2.8 | |
| K261002 | 2026-06-02 | Biomet Microfixation | Pectus Blu System | |
| K261038 | 2026-05-29 | Newclip Technics | Xpert PFP | |
| K261145 | 2026-05-09 | Avanti Orthopaedics, LLC | Avanti Distal Elbow ORIF System | |
| K260323 | 2026-04-30 | OrthoPediatrics Corp. | OrthoPediatrics® Locking Cannulated Blade Plate Syst… | |
| K260054 | 2026-04-24 | I.T.S. GmbH | I.T.S. PRS Phoenix II | |
| K260228 | 2026-04-24 | Bonebridge AG | POYA 3.5mm Medial Proximal Tibia System | |
| K260411 | 2026-04-24 | Chest Wall Innovations, Inc. | PC Fix System | |
| K260090 | 2026-04-10 | Actis Medical Pty., Ltd. | SMART Osteotomy System | |
| K253718 | 2026-04-01 | Nvision Biomedical Technologies, Inc. | enHAnce PEEK Bunion System | |
| K260274 | 2026-03-25 | Novastep SAS | Airlock® Ankle Plating System | |
| K260291 | 2026-03-25 | Nvision Biomedical Technologies, Inc. | Vortex5 Tailor's Bunion Correction System | |
| K254253 | 2026-03-24 | Aap Implantate AG | LOQTEQ® VA Proximal Humerus Plate 3.5 | |
| K254288 | 2026-03-23 | Skeletal Dynamics, Inc. | Clavicle Fixation System | |
| K260448 | 2026-03-19 | L&K BIOMED Co., Ltd. | CastleLoc Pectus Bar System | |
| K254053 | 2026-03-17 | A Plus Biotechnology Co., Ltd. | APS Spear Locking Plate | |
| K260390 | 2026-03-17 | GM Dos Reis Industria e Comercio Ltda. | Super Upper Limbs Versalock Plating System | |
| K253916 | 2026-03-16 | Medartis AG | APTUS Shoulder Proximal Humerus System, PentaLock 3.… | |
| K253906 | 2026-03-11 | Newclip Technics | Xpert Hand | FDA |
| K254093 | 2026-03-10 | Synthes GmbH | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating … | |
| K260069 | 2026-03-09 | Synthes GmbH | DePuy Synthes VOLT Proximal Tibia 3.5 Plating Syste… | |
| K260353 | 2026-03-03 | Arthrex, Inc. | Arthrex Humeral Plating System (Anatomic Humeral Pla… | |
| K254054 | 2026-03-02 | Synthes GmbH | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Cal… | |
| K254249 | 2026-02-27 | Hankil Tech Medical Co., Ltd. | HKT Anatomical Locking Trauma System | |
| K252166 | 2026-02-26 | Globus Medical, Inc. | RIB LINK Fixation System | |
| K253660 | 2026-02-20 | KLS-Martin L.P. | KLS Martin Pure Pectus System | |
| K254162 | 2026-02-20 | KLS Martin L.P. | KLS Martin Ixos System | |
| K251732 | 2026-02-12 | Met One Technologies, LLC | Wrist Fracture System | |
| K253713 | 2026-01-21 | Arthrex, Inc. | Arthrex Variable Angle (VA) Proximal Tibia Plating S… | |
| K254002 | 2026-01-15 | TriMed, Inc. | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Vo… | |
| K252807 | 2026-01-12 | Arthrex, Inc. | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus P… | |
| K253178 | 2026-01-06 | Crossroads Extremity Systems | TRILEAP Plating System | |
| K251050 | 2025-12-19 | Gm Dos Reis Industria E Comercio | Pectus Versa System | |
| K252191 | 2025-12-17 | Bonebridge AG | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal … | |
| K252897 | 2025-12-11 | A Plus Biotechnology Co., Ltd. | APS Osteotomy Fixation System (0945-1302-xx /4.5mm C… | |
| K250988 | 2025-12-11 | KLS-Martin L.P. | KLS Martin Pure Pectus System | |
| K252997 | 2025-12-11 | Hyperflex Medical | HyperFlex® Bunion Correction System | |
| K252661 | 2025-11-19 | Fusion Innovations, LLC | SternaFuse Ti Fixation System | |
| K253423 | 2025-11-18 | Nvision Biomedical Technologies, Inc. | ToeJack MIS Bunion System | |
| K250865 | 2025-11-14 | KLS-Martin L.P. | KLS Martin IPS Forearm System | |
| K252949 | 2025-11-13 | Skeletal Dynamics, Inc. | Geminus Volar Distal Radius Plating System | |
| K252959 | 2025-11-12 | Intrauma S.P.A | WRISTAR MultiAx Distal Radius Kit | FDA |
| K253300 | 2025-10-28 | Bodycad Laboratories, Inc. | Fine Osteotomy | |
| K252600 | 2025-10-09 | OrthoPediatrics Corp. | Pediatric Plating Platform I Small-Mini | |
| K251892 | 2025-09-08 | Maxxos Medical GmbH | MAXXOS P.A.C.E. Foot & Ankle Plating System | |
| K252356 | 2025-08-21 | Acumed, LLC | The Acumed Wrist Fixation System - 2.4mm Screws | |
| K250923 | 2025-08-21 | Bodycad Laboratories, Inc. | Fine Osteotomy | |
| K251135 | 2025-08-21 | Treace Medical Concepts | Treace Medical Concepts (TMC) Implant Fixation Syste… | |
| K252061 | 2025-08-20 | TriMed, Inc. | Distal Xtremities System | |
| K251161 | 2025-08-18 | Globus Medical, Inc. | ANTHEM® Fracture System | |
| K251913 | 2025-08-16 | OsteoCentric Technologies | OsteoCentric® UnifiMI® TCS Plating System | |
| K250620 | 2025-08-15 | KLS Martin L.P. | KLS Martin Ixos System | |
| K251361 | 2025-07-30 | Tyber Medical, LLC | Tyber Medical Distal Radius Plating System | |
| K251620 | 2025-07-25 | Zimmer Biomet | A.L.P.S. Proximal Humerus Plating System | |
| K250952 | 2025-07-18 | Paragon 28, Inc. | Baby Gorilla®/Gorilla® Plating System | |
| K251132 | 2025-07-14 | Acumed, LLC | The Acumed Wrist Fixation System - Plates; The Acume… | |
| K251945 | 2025-07-10 | TriMed, Inc. | TriMed Total Wrist Fusion System (Total Wrist Fusion… | |
| K242988 | 2025-06-27 | Genostis AF | Genostis Osteosynthesis System | |
| K250929 | 2025-06-26 | TriMed, Inc. | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compr… | |
| K243275 | 2025-06-26 | Exactech, Inc. | Equinoxe® Scapula Fracture System | FDA |
| K251296 | 2025-06-18 | Acumed, LLC | The Acumed Wrist Fixation System | FDA |
| K250933 | 2025-06-11 | Bonebridge AG | LORRAINE 2.5/3.5mm Distal Humerus System | |
| K243368 | 2025-06-04 | Medifield Medical Co., Ltd. | Montblanc Plate System | |
| K242751 | 2025-05-30 | Jeil Medical Corporation | ARIX Pectus Bar System | |
| K243469 | 2025-05-29 | Osteonic Co., Ltd. | SIGNEX | |
| K250935 | 2025-05-22 | TriMed, Inc. | TriMed Fifth Metatarsal System (Fifth Metatarsal Pla… | |
| K243963 | 2025-04-29 | OrthoPediatrics Corp. | Pediatric Plating Platform Hip | |
| K250892 | 2025-04-25 | L&K BIOMED Co., Ltd. | CastleLoc Pectus Bar System | FDA |
| K242973 | 2025-04-24 | Canwell Medical Co., Ltd. | CanMINI Hand and Foot System | FDA |
| K250155 | 2025-04-23 | Newclip Technics | Xpert Knee | |
| K250948 | 2025-04-08 | TriMed, Inc. | TriMed Fusion Cup System | |
| K243995 | 2025-03-26 | Arthrex, Inc. | Arthrex Humeral Plating System and Cerclage Button | |
| K243987 | 2025-03-19 | TriMed, Inc. | TriMed Elbow and Forearm System | |
| K242486 | 2025-03-19 | Tyber Medical, LLC | Tyber Medical Anatomical Plating System | |
| K243999 | 2025-03-19 | TriMed, Inc. | TriMed Ankle Fixation System | |
| K250494 | 2025-03-18 | OsteoCentric Technologies | The OsteoCentric Bone Plate and Screw System | |
| K250498 | 2025-03-17 | Orthonovis, Inc. | BPS Wrist Fracture System | |
| K243610 | 2025-03-07 | Medartis AG | APTUS Hand System; APTUS Elbow Dorsal Olecranon | |
| K243357 | 2025-02-27 | L&K BIOMED Co., Ltd. | CastleLoc Pectus Bar System | |
| K241666 | 2025-02-19 | Smith & Nephew | EVOS Pelvic and Acetabular System | |
| K243761 | 2025-02-19 | Biomet Orthopedics | A.L.P.S. Small Fragment Plating System | |
| K240958 | 2025-02-10 | Hebei Ruihe Medical Devices Co., Ltd. | Locking Plates and Screws Systems | |
| K250055 | 2025-02-06 | Orthonovis, Inc. | BPS - Bone Fragment Fixation Plates, Screws and Wash… | |
| K241599 | 2025-02-06 | Signature Orthopaedic Pty , Ltd. | Signature Osteosynthesis Plate System | |
| K243740 | 2025-01-29 | GM Dos Reis Industria e Comercio Ltda. | Versalock Upper Limb Plating System | FDA |
| K243569 | 2025-01-15 | TriMed, Inc. | TriMed Wrist Fixation System (Volar Bearing Plates);… | |
| K242939 | 2024-12-23 | Artfx Medical | ARTFX Trauma Bone Plate and Screw System | |
| K243308 | 2024-12-20 | Bonebridge AG | Bonebridge Osteosynthesis Plating System (SALGINA 2.… | FDA |
| K243491 | 2024-12-11 | Stryker Leibinger GmbH & Co KG | SternalPlate Expansion | |
| K241128 | 2024-12-05 | Tdm Co., Ltd. | TDM Plate and Screw System | |
| K243050 | 2024-11-26 | TriMed, Inc. | TriMed Posterior Malleolus Fixation System | |
| K241995 | 2024-11-26 | Footbridge Medical | HyperFlex Bunion Correction System | |
| K242998 | 2024-11-21 | GM Dos Reis Industria e Comercio Ltda. | GMReis Ankle Plating System | |
| K242596 | 2024-11-21 | GM Dos Reis Industria e Comercio Ltda. | Versalock Mini and Micro Plating System | |
| K242079 | 2024-11-14 | Arthrex, Inc. | Arthrex Elbow Fracture Plating System | |
| K242436 | 2024-11-14 | Skeletal Dynamics, Inc. | Proximal Humerus Fixation System | |
| K242814 | 2024-11-14 | Microware Precision Co., Ltd. | Tandry Q-Locking Plate System | FDA |
| K240388 | 2024-11-01 | 4Web Medical, Inc. | Osteotomy Truss System (OTS) | |
| K242399 | 2024-10-31 | Bonebridge AG | Bonebridge Osteosynthesis Plating System | |
| K242995 | 2024-10-23 | The Orthopaedic Implant Company | OIC Small / Mini Fragment Plate System | |
| K242554 | 2024-10-21 | Arthrex, Inc. | Arthrex VAL and VAL KreuLock Compression Screw Syst… | |
| K240181 | 2024-10-09 | Auxein Medical Pvt., Ltd. | Clavicle and Scapula System | |
| K242445 | 2024-10-06 | Stryker GmbH | Pangea Platform; Pangea Femur Plating System; Pangea… | |
| K242343 | 2024-10-04 | Orthonovis, Inc. | BPS Wrist Fracture System | |
| K241815 | 2024-09-26 | Skeletal Dynamics, Inc. | Protean Fragment Plating System | FDA |
| K241709 | 2024-09-19 | Biomet Microfixation | Pectus Blu Support Bar System | FDA |
| K241942 | 2024-09-17 | TriMed, Inc. | TriMed Bridge Plates | |
| K241356 | 2024-09-05 | Bodycad Laboratories, Inc. | Fine Osteotomy | |
| K240487 | 2024-09-03 | Smith & Nephew | EVOS Patella Plates | |
| K233816 | 2024-08-28 | Vilex, LLC | REDEMPTION Charcot Plating System | |
| K240318 | 2024-08-23 | Bonebridge AG | SITTER 3.5mm Versatile System | |
| K241282 | 2024-08-19 | Riverpoint Medical | RibFix Titan Fixation System | |
| K241754 | 2024-08-15 | Zimmer Switzerland Manufacturing GmbH | NCB® Polyaxial Locking Plate System; NCB® Periprosth… | |
| K241387 | 2024-08-13 | In2bones USA | CoLink NeoFuse MIS Plating System (see attached part… | FDA |
| K242055 | 2024-08-01 | Skeletal Dynamics, Inc. | Freefix Forearm Plating System | |
| K241539 | 2024-07-30 | Newclip Technics | Activmotion S | |
| K233994 | 2024-07-26 | Synthes GmbH | VOLT Proximal Humerus 3.5 Plating System | |
| K241296 | 2024-07-23 | Netbiologics, LLC | Gaudi Proximal Humerus Plate | |
| K241018 | 2024-07-12 | KLS-Martin L.P. | KLS Martin Orthopedic Implants - MR Conditional | |
| K234059 | 2024-06-26 | Forma Medical, Inc. | Forma Medical Optimal Plating System | |
| K232829 | 2024-06-26 | GM Dos Reis Industria e Comercio Ltda. | Versalock Rib and Sternum Plates System | |
| K240613 | 2024-06-20 | Medartis AG | APTUS Elbow Dorsal Olecranon Plates | |
| K230546 | 2024-06-11 | Osteonic Co., Ltd. | SIGNEX | |
| K241262 | 2024-06-05 | Paragon 28, Inc. | Baby Gorilla/Gorilla Plating System; Monster Screw S… | |
| K241218 | 2024-05-31 | Tyber Medical, LLC | Tyber Medical Anatomical Plating System | |
| K233089 | 2024-05-24 | In2bones USA, LLC | NeoSpan® Compression Implant System | |
| K233967 | 2024-05-09 | Synthes GmbH | DePuy Synthes MatrixSTERNUM Fixation System | |
| K233873 | 2024-04-26 | Ortho Life Systems Private Limited | XLO Brand of Locking Distal Humerus Plating System | |
| K233311 | 2024-04-22 | Acumed, LLC | Acumed Wrist Plating System | |
| K232105 | 2024-04-19 | Medartis AG | APTUS Foot System 2.8-3.5 | |
| K233863 | 2024-04-17 | TriMed, Inc. | TriMed ASET Foot Plating System (1ST MTP 9-hole Lon… | |
| K240703 | 2024-04-12 | Bodycad Laboratories, Inc. | Fine Osteotomy | |
| K232115 | 2024-04-05 | Tdm Co., Ltd. | TDM Large Bone Plate and Screw System | |
| K233919 | 2024-03-25 | Stryker GmbH | VariAx 2 Distal Radius System | |
| K233665 | 2024-03-21 | DePuy Synthes | DePuy Synthes VOLT Mini Fragment Plating System, DeP… | |
| K234062 | 2024-03-21 | Medartis AG | APTUS Hand Scaphoid Plates | |
| K240173 | 2024-02-22 | Treace Medical Concepts, Inc. | Treace Medical Systems (TMC) Plating System | |
| K231213 | 2024-01-19 | Hankil Tech Medical Co., Ltd. | HKT Anatomical Locking Trauma System | |
| K234031 | 2024-01-18 | Medline Industires, LP | Medline UNITE Ancillary Foot Recon Plating System | |
| K231684 | 2024-01-12 | GM Dos Reis Industria e Comercio Ltda. | Quick - Radius Disposable Set | |
| K233154 | 2023-12-21 | Sky Surgical, LLC | SkyOPS Orthopedic Plate System | |
| K233423 | 2023-12-21 | Tyber Medical, LLC | Tyber Medical Anatomical Plating System Line exten… | |
| K233017 | 2023-12-20 | Tyber Medical, LLC | TM Plating System | |
| K232394 | 2023-12-15 | Changzhou Geasure Medical Apparatus an… | Internal Locking Plate and Screw Fixation System | FDA |
| K231887 | 2023-12-14 | Jeil Medical Corporation | ARIX Ankle Distal Tibia System | |
| K232652 | 2023-12-13 | Tyber Medical, LLC | Anatomical Plating System (various) | |
| K232515 | 2023-12-08 | Jm Longyear Manufacturing, LLC D/B/A A… | Valkyrie Thoracic Fixation System | |
| K232693 | 2023-12-04 | Tyber Medical, LLC | Tyber Medical Distal Radius Plating System | |
| K230591 | 2023-09-29 | Crossroads Extremity Systems | TriLEAP Plating System | |
| K223933 | 2023-09-25 | Exactech, Inc. | Exactech Equinoxe PHx Fracture System; Exactech EPIC… |
Official FDA classification page: HRS
Classification and pathway per current FDA publications. Data from openFDA (CC0).