FDA Product Code
FDA Product Code HRS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 1,329 records · page 1 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261611 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2026-10-02 | Special | PDF ↗ |
| K262649 | Alians Forearm | Newclip Technics | 2026-09-28 | Traditional | PDF ↗ |
| K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026-09-23 | Traditional | PDF ↗ |
| K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026-09-18 | Special | PDF ↗ |
| K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026-09-15 | Special | PDF ↗ |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | 2026-09-03 | Traditional | PDF ↗ |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026-08-28 | Traditional | PDF ↗ |
| K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-08-19 | Special | PDF ↗ |
| K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | 2026-08-13 | Traditional | PDF ↗ |
| K261511 | Xpert Ankle | Newclip Technics | 2026-07-28 | Traditional | PDF ↗ |
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 | Traditional | PDF ↗ |
| 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. | 2026-07-16 | Special | PDF ↗ |
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 | Traditional | PDF ↗ |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 | Traditional | PDF ↗ |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026-06-26 | Traditional | PDF ↗ |
| 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 | 2026-06-16 | Traditional | PDF ↗ |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026-06-12 | Traditional | PDF ↗ |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026-06-05 | Traditional | PDF ↗ |
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 | Traditional | PDF ↗ |
| K261038 | Xpert PFP | Newclip Technics | 2026-05-29 | Traditional | PDF ↗ |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026-05-09 | Abbreviated | PDF ↗ |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 | Traditional | PDF ↗ |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026-04-24 | Traditional | PDF ↗ |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026-04-24 | Traditional | PDF ↗ |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 | Traditional | PDF ↗ |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | 2026-04-10 | Traditional | PDF ↗ |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026-04-01 | Traditional | PDF ↗ |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | 2026-03-25 | Abbreviated | PDF ↗ |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026-03-25 | Traditional | PDF ↗ |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | 2026-03-24 | Traditional | PDF ↗ |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | 2026-03-23 | Abbreviated | PDF ↗ |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026-03-19 | Special | PDF ↗ |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | 2026-03-17 | Traditional | PDF ↗ |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 | Traditional | PDF ↗ |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | 2026-03-16 | Traditional | PDF ↗ |
| K253906 | Xpert Hand | Newclip Technics | 2026-03-11 | Traditional | PDF ↗ |
| K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | Synthes GmbH | 2026-03-10 | Traditional | PDF ↗ |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | Synthes GmbH | 2026-03-09 | Traditional | PDF ↗ |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | 2026-03-03 | Special | PDF ↗ |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | Synthes GmbH | 2026-03-02 | Traditional | PDF ↗ |
| K254249 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | 2026-02-27 | Traditional | PDF ↗ |
| K252166 | RIB LINK Fixation System | Globus Medical, Inc. | 2026-02-26 | Traditional | PDF ↗ |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | 2026-02-20 | Traditional | PDF ↗ |
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2026-02-20 | Traditional | PDF ↗ |
| K251732 | Wrist Fracture System | Met One Technologies, LLC | 2026-02-12 | Traditional | PDF ↗ |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | 2026-01-21 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. | 2026-01-12 | Traditional | PDF ↗ |
| K253178 | TRILEAP Plating System | Crossroads Extremity Systems | 2026-01-06 | Traditional | PDF ↗ |
| K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio | 2025-12-19 | Traditional | PDF ↗ |
| K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG | 2025-12-17 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K252997 | HyperFlex® Bunion Correction System | Hyperflex Medical | 2025-12-11 | Traditional | PDF ↗ |
| K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2025-12-11 | Traditional | PDF ↗ |
| K252661 | SternaFuse Ti Fixation System | Fusion Innovations, LLC | 2025-11-19 | Traditional | PDF ↗ |
| K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2025-11-18 | Traditional | PDF ↗ |
| K250865 | KLS Martin IPS Forearm System | KLS-Martin L.P. | 2025-11-14 | Traditional | PDF ↗ |
| K252949 | Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. | 2025-11-13 | Traditional | PDF ↗ |
| K252959 | WRISTAR MultiAx Distal Radius Kit | Intrauma S.P.A | 2025-11-12 | Traditional | PDF ↗ |
| K253300 | Fine Osteotomy | Bodycad Laboratories, Inc. | 2025-10-28 | Special | PDF ↗ |
| K252600 | Pediatric Plating Platform I Small-Mini | OrthoPediatrics Corp. | 2025-10-09 | Traditional | PDF ↗ |
| K251892 | MAXXOS P.A.C.E. Foot & Ankle Plating System | Maxxos Medical GmbH | 2025-09-08 | Traditional | PDF ↗ |
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | Acumed, LLC | 2025-08-21 | Special | PDF ↗ |
| K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025-08-21 | Special | PDF ↗ |
| K250923 | Fine Osteotomy | Bodycad Laboratories, Inc. | 2025-08-21 | Traditional | PDF ↗ |
| K252061 | Distal Xtremities System | TriMed, Inc. | 2025-08-20 | Traditional | PDF ↗ |
| K251161 | ANTHEM® Fracture System | Globus Medical, Inc. | 2025-08-18 | Traditional | PDF ↗ |
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | OsteoCentric Technologies | 2025-08-16 | Special | PDF ↗ |
| K250620 | KLS Martin Ixos System | KLS Martin L.P. | 2025-08-15 | Traditional | PDF ↗ |
| K251361 | Tyber Medical Distal Radius Plating System | Tyber Medical, LLC | 2025-07-30 | Traditional | PDF ↗ |
| K251620 | A.L.P.S. Proximal Humerus Plating System | Zimmer Biomet | 2025-07-25 | Traditional | PDF ↗ |
| K250952 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2025-07-18 | Traditional | PDF ↗ |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | Acumed, LLC | 2025-07-14 | Abbreviated | PDF ↗ |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | TriMed, Inc. | 2025-07-10 | Special | PDF ↗ |
| K242988 | Genostis Osteosynthesis System | Genostis AF | 2025-06-27 | Traditional | PDF ↗ |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | TriMed, Inc. | 2025-06-26 | Traditional | PDF ↗ |
| K243275 | Equinoxe® Scapula Fracture System | Exactech, Inc. | 2025-06-26 | Traditional | PDF ↗ |
| K251296 | The Acumed Wrist Fixation System | Acumed, LLC | 2025-06-18 | Traditional | PDF ↗ |
| K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | Bonebridge AG | 2025-06-11 | Traditional | PDF ↗ |
| K243368 | Montblanc Plate System | Medifield Medical Co., Ltd. | 2025-06-04 | Traditional | PDF ↗ |
| K242751 | ARIX Pectus Bar System | Jeil Medical Corporation | 2025-05-30 | Traditional | PDF ↗ |
| K243469 | SIGNEX | Osteonic Co., Ltd. | 2025-05-29 | Traditional | PDF ↗ |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | TriMed, Inc. | 2025-05-22 | Traditional | PDF ↗ |
| K243963 | Pediatric Plating Platform Hip | OrthoPediatrics Corp. | 2025-04-29 | Traditional | PDF ↗ |
| K250892 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025-04-25 | Special | PDF ↗ |
| K242973 | CanMINI Hand and Foot System | Canwell Medical Co., Ltd. | 2025-04-24 | Abbreviated | PDF ↗ |
| K250155 | Xpert Knee | Newclip Technics | 2025-04-23 | Traditional | PDF ↗ |
| K250948 | TriMed Fusion Cup System | TriMed, Inc. | 2025-04-08 | Special | PDF ↗ |
| K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. | 2025-03-26 | Traditional | PDF ↗ |
| K243987 | TriMed Elbow and Forearm System | TriMed, Inc. | 2025-03-19 | Traditional | PDF ↗ |
| K242486 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2025-03-19 | Traditional | PDF ↗ |
| K243999 | TriMed Ankle Fixation System | TriMed, Inc. | 2025-03-19 | Traditional | PDF ↗ |
| K250494 | The OsteoCentric Bone Plate and Screw System | OsteoCentric Technologies | 2025-03-18 | Special | PDF ↗ |
| K250498 | BPS Wrist Fracture System | Orthonovis, Inc. | 2025-03-17 | Special | PDF ↗ |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025-03-07 | Traditional | PDF ↗ |
| K243357 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025-02-27 | Traditional | PDF ↗ |
| K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | 2025-02-19 | Traditional | PDF ↗ |
| K241666 | EVOS Pelvic and Acetabular System | Smith & Nephew | 2025-02-19 | Traditional | PDF ↗ |
| K240958 | Locking Plates and Screws Systems | Hebei Ruihe Medical Devices Co., Ltd. | 2025-02-10 | Abbreviated | PDF ↗ |
| K241599 | Signature Osteosynthesis Plate System | Signature Orthopaedic Pty , Ltd. | 2025-02-06 | Traditional | PDF ↗ |
Product code HRS · Class II · Orthopedic. Data: openFDA.