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HRS

Plate, Fixation, Bone

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)

Last three years. Most recent: 2026-08-28.

NumberDecision dateApplicantDevice nameSummary
K2618302026-08-28Ortler Global Tibbi Gerecler Anonim Si…FRAXION 3.5 Plate System (Various - See Catalog);FRA…PDF
K2625372026-08-19GM Dos Reis Industria e Comercio Ltda.Versalock Sterile Plating SystemPDF
K2602772026-08-13Mikron Makina San. ve Tic. Ltd. Sti.MIKRON TRAUMA BONE PLATE& SCREW SYSTEMPDF
K2615112026-07-28Newclip TechnicsXpert AnklePDF
K2614062026-07-21GM Dos Reis Industria e Comercio Ltda.Versalock Proximal Tibial Plating SystemPDF
K2620322026-07-16TriMed, Inc.TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);T…PDF
K2611912026-07-08Newclip TechnicsAlians Elbow SPDF
K2610542026-07-01Stryker Leibinger GmbH & Co KGRibPlate SystemPDF
K2613512026-06-26Bonebridge AGSALGINA 2.5mm Distal Radius SystemPDF
K2609582026-06-16I.T.S. GmbHI.T.S. Clavicle Plates with Angular Stability; I.T.S…FDA
K2612072026-06-12Tyber Medical, LLCExalta Proximal Tibia Plating SystemPDF
K2607612026-06-05Medartis AGAPTUS Clavicle System 2.8PDF
K2610022026-06-02Biomet MicrofixationPectus Blu SystemPDF
K2610382026-05-29Newclip TechnicsXpert PFPPDF
K2611452026-05-09Avanti Orthopaedics, LLCAvanti Distal Elbow ORIF SystemPDF
K2603232026-04-30OrthoPediatrics Corp.OrthoPediatrics® Locking Cannulated Blade Plate Syst…PDF
K2600542026-04-24I.T.S. GmbHI.T.S. PRS Phoenix IIPDF
K2602282026-04-24Bonebridge AGPOYA 3.5mm Medial Proximal Tibia SystemPDF
K2604112026-04-24Chest Wall Innovations, Inc.PC Fix SystemPDF
K2600902026-04-10Actis Medical Pty., Ltd.SMART Osteotomy SystemPDF
K2537182026-04-01Nvision Biomedical Technologies, Inc.enHAnce PEEK Bunion SystemPDF
K2602742026-03-25Novastep SASAirlock® Ankle Plating SystemPDF
K2602912026-03-25Nvision Biomedical Technologies, Inc.Vortex5 Tailor's Bunion Correction SystemPDF
K2542532026-03-24Aap Implantate AGLOQTEQ® VA Proximal Humerus Plate 3.5PDF
K2542882026-03-23Skeletal Dynamics, Inc.Clavicle Fixation SystemPDF
K2604482026-03-19L&K BIOMED Co., Ltd.CastleLoc Pectus Bar SystemPDF
K2540532026-03-17A Plus Biotechnology Co., Ltd.APS Spear Locking PlatePDF
K2603902026-03-17GM Dos Reis Industria e Comercio Ltda.Super Upper Limbs Versalock Plating SystemPDF
K2539162026-03-16Medartis AGAPTUS Shoulder Proximal Humerus System, PentaLock 3.…PDF
K2539062026-03-11Newclip TechnicsXpert HandFDA
K2540932026-03-10Synthes GmbHDePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating …PDF
K2600692026-03-09Synthes GmbHDePuy Synthes VOLT™ Proximal Tibia 3.5 Plating Syste…PDF
K2603532026-03-03Arthrex, Inc.Arthrex Humeral Plating System (Anatomic Humeral Pla…PDF
K2540542026-03-02Synthes GmbHVOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Cal…PDF
K2542492026-02-27Hankil Tech Medical Co., Ltd.HKT Anatomical Locking Trauma SystemPDF
K2521662026-02-26Globus Medical, Inc.RIB LINK™ Fixation SystemPDF
K2536602026-02-20KLS-Martin L.P.KLS Martin Pure Pectus SystemPDF
K2541622026-02-20KLS Martin L.P.KLS Martin Ixos SystemPDF
K2517322026-02-12Met One Technologies, LLCWrist Fracture SystemPDF
K2537132026-01-21Arthrex, Inc.Arthrex Variable Angle (VA) Proximal Tibia Plating S…PDF
K2540022026-01-15TriMed, Inc.TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Vo…PDF
K2528072026-01-12Arthrex, Inc.Arthrex Anatomic Lapidus Plates and I-Beam Lapidus P…PDF
K2531782026-01-06Crossroads Extremity SystemsTRILEAP Plating SystemPDF
K2510502025-12-19Gm Dos Reis Industria E ComercioPectus Versa SystemPDF
K2521912025-12-17Bonebridge AGBRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal …PDF
K2528972025-12-11A Plus Biotechnology Co., Ltd.APS Osteotomy Fixation System (0945-1302-xx /4.5mm C…PDF
K2509882025-12-11KLS-Martin L.P.KLS Martin Pure Pectus SystemPDF
K2529972025-12-11Hyperflex MedicalHyperFlex® Bunion Correction SystemPDF
K2526612025-11-19Fusion Innovations, LLCSternaFuse Ti Fixation SystemPDF
K2534232025-11-18Nvision Biomedical Technologies, Inc.ToeJack MIS Bunion SystemPDF
K2508652025-11-14KLS-Martin L.P.KLS Martin IPS Forearm SystemPDF
K2529492025-11-13Skeletal Dynamics, Inc.Geminus Volar Distal Radius Plating SystemPDF
K2529592025-11-12Intrauma S.P.AWRISTAR MultiAx Distal Radius KitFDA
K2533002025-10-28Bodycad Laboratories, Inc.Fine Osteotomy™PDF
K2526002025-10-09OrthoPediatrics Corp.Pediatric Plating Platform I Small-MiniPDF
K2518922025-09-08Maxxos Medical GmbHMAXXOS P.A.C.E. Foot & Ankle Plating SystemPDF
K2523562025-08-21Acumed, LLCThe Acumed Wrist Fixation System - 2.4mm ScrewsPDF
K2509232025-08-21Bodycad Laboratories, Inc.Fine Osteotomy™PDF
K2511352025-08-21Treace Medical ConceptsTreace Medical Concepts (TMC) Implant Fixation Syste…PDF
K2520612025-08-20TriMed, Inc.Distal Xtremities SystemPDF
K2511612025-08-18Globus Medical, Inc.ANTHEM® Fracture SystemPDF
K2519132025-08-16OsteoCentric TechnologiesOsteoCentric® UnifiMI® TCS Plating SystemPDF
K2506202025-08-15KLS Martin L.P.KLS Martin Ixos SystemPDF
K2513612025-07-30Tyber Medical, LLCTyber Medical Distal Radius Plating SystemPDF
K2516202025-07-25Zimmer BiometA.L.P.S. Proximal Humerus Plating SystemPDF
K2509522025-07-18Paragon 28, Inc.Baby Gorilla®/Gorilla® Plating SystemPDF
K2511322025-07-14Acumed, LLCThe Acumed Wrist Fixation System - Plates; The Acume…PDF
K2519452025-07-10TriMed, Inc.TriMed Total Wrist Fusion System (Total Wrist Fusion…PDF
K2429882025-06-27Genostis AFGenostis Osteosynthesis SystemPDF
K2509292025-06-26TriMed, Inc.TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compr…PDF
K2432752025-06-26Exactech, Inc.Equinoxe® Scapula Fracture SystemFDA
K2512962025-06-18Acumed, LLCThe Acumed Wrist Fixation SystemFDA
K2509332025-06-11Bonebridge AGLORRAINE 2.5/3.5mm Distal Humerus SystemPDF
K2433682025-06-04Medifield Medical Co., Ltd.Montblanc Plate SystemPDF
K2427512025-05-30Jeil Medical CorporationARIX Pectus Bar SystemPDF
K2434692025-05-29Osteonic Co., Ltd.SIGNEXPDF
K2509352025-05-22TriMed, Inc.TriMed Fifth Metatarsal System (Fifth Metatarsal Pla…PDF
K2439632025-04-29OrthoPediatrics Corp.Pediatric Plating Platform HipPDF
K2508922025-04-25L&K BIOMED Co., Ltd.CastleLoc Pectus Bar SystemFDA
K2429732025-04-24Canwell Medical Co., Ltd.CanMINI Hand and Foot SystemFDA
K2501552025-04-23Newclip TechnicsXpert KneePDF
K2509482025-04-08TriMed, Inc.TriMed Fusion Cup SystemPDF
K2439952025-03-26Arthrex, Inc.Arthrex Humeral Plating System and Cerclage ButtonPDF
K2439872025-03-19TriMed, Inc.TriMed Elbow and Forearm SystemPDF
K2424862025-03-19Tyber Medical, LLCTyber Medical Anatomical Plating SystemPDF
K2439992025-03-19TriMed, Inc.TriMed Ankle Fixation SystemPDF
K2504942025-03-18OsteoCentric TechnologiesThe OsteoCentric Bone Plate and Screw SystemPDF
K2504982025-03-17Orthonovis, Inc.BPS Wrist Fracture SystemPDF
K2436102025-03-07Medartis AGAPTUS Hand System; APTUS Elbow Dorsal OlecranonPDF
K2433572025-02-27L&K BIOMED Co., Ltd.CastleLoc Pectus Bar SystemPDF
K2416662025-02-19Smith & NephewEVOS Pelvic and Acetabular SystemPDF
K2437612025-02-19Biomet OrthopedicsA.L.P.S. Small Fragment Plating SystemPDF
K2409582025-02-10Hebei Ruihe Medical Devices Co., Ltd.Locking Plates and Screws SystemsPDF
K2500552025-02-06Orthonovis, Inc.BPS - Bone Fragment Fixation Plates, Screws and Wash…PDF
K2415992025-02-06Signature Orthopaedic Pty , Ltd.Signature Osteosynthesis Plate SystemPDF
K2437402025-01-29GM Dos Reis Industria e Comercio Ltda.Versalock Upper Limb Plating SystemFDA
K2435692025-01-15TriMed, Inc.TriMed Wrist Fixation System (Volar Bearing Plates);…PDF
K2429392024-12-23Artfx MedicalARTFX Trauma Bone Plate and Screw SystemPDF
K2433082024-12-20Bonebridge AGBonebridge Osteosynthesis Plating System (SALGINA 2.…FDA
K2434912024-12-11Stryker Leibinger GmbH & Co KGSternalPlate ExpansionPDF
K2411282024-12-05Tdm Co., Ltd.TDM Plate and Screw SystemPDF
K2430502024-11-26TriMed, Inc.TriMed Posterior Malleolus Fixation SystemPDF
K2419952024-11-26Footbridge MedicalHyperFlex™ Bunion Correction SystemPDF
K2429982024-11-21GM Dos Reis Industria e Comercio Ltda.GMReis Ankle Plating SystemPDF
K2425962024-11-21GM Dos Reis Industria e Comercio Ltda.Versalock Mini and Micro Plating SystemPDF
K2420792024-11-14Arthrex, Inc.Arthrex Elbow Fracture Plating SystemPDF
K2424362024-11-14Skeletal Dynamics, Inc.Proximal Humerus Fixation SystemPDF
K2428142024-11-14Microware Precision Co., Ltd.Tandry Q-Locking Plate SystemFDA
K2403882024-11-014Web Medical, Inc.Osteotomy Truss System (OTS)PDF
K2423992024-10-31Bonebridge AGBonebridge Osteosynthesis Plating SystemPDF
K2429952024-10-23The Orthopaedic Implant CompanyOIC Small / Mini Fragment Plate SystemPDF
K2425542024-10-21Arthrex, Inc.Arthrex VAL and VAL KreuLock™ Compression Screw Syst…PDF
K2401812024-10-09Auxein Medical Pvt., Ltd.Clavicle and Scapula SystemPDF
K2424452024-10-06Stryker GmbHPangea Platform; Pangea Femur Plating System; Pangea…PDF
K2423432024-10-04Orthonovis, Inc.BPS Wrist Fracture SystemPDF
K2418152024-09-26Skeletal Dynamics, Inc.Protean Fragment Plating SystemFDA
K2417092024-09-19Biomet MicrofixationPectus Blu Support Bar SystemFDA
K2419422024-09-17TriMed, Inc.TriMed Bridge PlatesPDF
K2413562024-09-05Bodycad Laboratories, Inc.Fine Osteotomy™PDF
K2404872024-09-03Smith & NephewEVOS Patella PlatesPDF
K2338162024-08-28Vilex, LLCREDEMPTION Charcot Plating SystemPDF
K2403182024-08-23Bonebridge AGSITTER 3.5mm Versatile SystemPDF
K2412822024-08-19Riverpoint MedicalRibFix Titan™ Fixation SystemPDF
K2417542024-08-15Zimmer Switzerland Manufacturing GmbHNCB® Polyaxial Locking Plate System; NCB® Periprosth…PDF
K2413872024-08-13In2bones USACoLink NeoFuse MIS Plating System (see attached part…FDA
K2420552024-08-01Skeletal Dynamics, Inc.Freefix Forearm Plating SystemPDF
K2415392024-07-30Newclip TechnicsActivmotion SPDF
K2339942024-07-26Synthes GmbHVOLT™ Proximal Humerus 3.5 Plating SystemPDF
K2412962024-07-23Netbiologics, LLCGaudi Proximal Humerus PlatePDF
K2410182024-07-12KLS-Martin L.P.KLS Martin Orthopedic Implants - MR ConditionalPDF
K2340592024-06-26Forma Medical, Inc.Forma Medical Optimal Plating SystemPDF
K2328292024-06-26GM Dos Reis Industria e Comercio Ltda.Versalock Rib and Sternum Plates SystemPDF
K2406132024-06-20Medartis AGAPTUS Elbow Dorsal Olecranon PlatesPDF
K2305462024-06-11Osteonic Co., Ltd.SIGNEXPDF
K2412622024-06-05Paragon 28, Inc.Baby Gorilla/Gorilla Plating System; Monster Screw S…PDF
K2412182024-05-31Tyber Medical, LLCTyber Medical Anatomical Plating SystemPDF
K2330892024-05-24In2bones USA, LLCNeoSpan® Compression Implant SystemPDF
K2339672024-05-09Synthes GmbHDePuy Synthes MatrixSTERNUM Fixation SystemPDF
K2338732024-04-26Ortho Life Systems Private LimitedXLO Brand of Locking Distal Humerus Plating SystemPDF
K2333112024-04-22Acumed, LLCAcumed Wrist Plating SystemPDF
K2321052024-04-19Medartis AGAPTUS Foot System 2.8-3.5PDF
K2338632024-04-17TriMed, Inc.TriMed ASET Foot Plating System (1ST MTP 9-hole Lon…PDF
K2407032024-04-12Bodycad Laboratories, Inc.Fine Osteotomy™PDF
K2321152024-04-05Tdm Co., Ltd.TDM Large Bone Plate and Screw SystemPDF
K2339192024-03-25Stryker GmbHVariAx 2 Distal Radius SystemPDF
K2336652024-03-21DePuy SynthesDePuy Synthes VOLT Mini Fragment Plating System, DeP…PDF
K2340622024-03-21Medartis AGAPTUS Hand Scaphoid PlatesPDF
K2401732024-02-22Treace Medical Concepts, Inc.Treace Medical Systems (TMC) Plating SystemPDF
K2312132024-01-19Hankil Tech Medical Co., Ltd.HKT Anatomical Locking Trauma SystemPDF
K2340312024-01-18Medline Industires, LPMedline UNITE Ancillary Foot Recon Plating SystemPDF
K2316842024-01-12GM Dos Reis Industria e Comercio Ltda.Quick - Radius Disposable SetPDF
K2331542023-12-21Sky Surgical, LLCSkyOPS™ Orthopedic Plate SystemPDF
K2334232023-12-21Tyber Medical, LLCTyber Medical Anatomical Plating System – Line exten…PDF
K2330172023-12-20Tyber Medical, LLCTM Plating SystemPDF
K2323942023-12-15Changzhou Geasure Medical Apparatus an…Internal Locking Plate and Screw Fixation SystemFDA
K2318872023-12-14Jeil Medical CorporationARIX Ankle Distal Tibia SystemPDF
K2326522023-12-13Tyber Medical, LLCAnatomical Plating System (various)PDF
K2325152023-12-08Jm Longyear Manufacturing, LLC D/B/A A…Valkyrie Thoracic Fixation SystemPDF
K2326932023-12-04Tyber Medical, LLCTyber Medical Distal Radius Plating SystemPDF
K2305912023-09-29Crossroads Extremity SystemsTriLEAP Plating SystemPDF
K2239332023-09-25Exactech, Inc.Exactech Equinoxe PHx Fracture System; Exactech EPIC…PDF

147 summaries are archived here for direct download.

Official FDA classification page: HRS
Classification and pathway per current FDA publications. Data from openFDA (CC0).