Members中文

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)
1323

510(k) clearances, last 3 years (161)

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

NumberDecision dateApplicantDevice name
K2618302026-08-28Ortler Global Tibbi Gerecler Anonim SiFRAXION 3.5 Plate System (Various - See Catalog);FRA summary
K2625372026-08-19GM Dos Reis Industria e Comercio Ltda.Versalock Sterile Plating System summary
K2602772026-08-13Mikron Makina San. ve Tic. Ltd. Sti.MIKRON TRAUMA BONE PLATE& SCREW SYSTEM summary
K2615112026-07-28Newclip TechnicsXpert Ankle summary
K2614062026-07-21GM Dos Reis Industria e Comercio Ltda.Versalock Proximal Tibial Plating System summary
K2620322026-07-16TriMed, Inc.TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);T summary
K2611912026-07-08Newclip TechnicsAlians Elbow S summary
K2610542026-07-01Stryker Leibinger GmbH & Co KGRibPlate System summary
K2613512026-06-26Bonebridge AGSALGINA 2.5mm Distal Radius System summary
K2609582026-06-16I.T.S. GmbHI.T.S. Clavicle Plates with Angular Stability; I.T.S summary
K2612072026-06-12Tyber Medical, LLCExalta Proximal Tibia Plating System summary
K2607612026-06-05Medartis AGAPTUS Clavicle System 2.8 summary
K2610022026-06-02Biomet MicrofixationPectus Blu System summary
K2610382026-05-29Newclip TechnicsXpert PFP summary
K2611452026-05-09Avanti Orthopaedics, LLCAvanti Distal Elbow ORIF System summary
K2603232026-04-30OrthoPediatrics Corp.OrthoPediatrics® Locking Cannulated Blade Plate Syst summary
K2600542026-04-24I.T.S. GmbHI.T.S. PRS Phoenix II summary
K2602282026-04-24Bonebridge AGPOYA 3.5mm Medial Proximal Tibia System summary
K2604112026-04-24Chest Wall Innovations, Inc.PC Fix System summary
K2600902026-04-10Actis Medical Pty., Ltd.SMART Osteotomy System summary
K2537182026-04-01Nvision Biomedical Technologies, Inc.enHAnce PEEK Bunion System summary
K2602742026-03-25Novastep SASAirlock® Ankle Plating System summary
K2602912026-03-25Nvision Biomedical Technologies, Inc.Vortex5 Tailor's Bunion Correction System summary
K2542532026-03-24Aap Implantate AGLOQTEQ® VA Proximal Humerus Plate 3.5 summary
K2542882026-03-23Skeletal Dynamics, Inc.Clavicle Fixation System summary
K2604482026-03-19L&K BIOMED Co., Ltd.CastleLoc Pectus Bar System summary
K2540532026-03-17A Plus Biotechnology Co., Ltd.APS Spear Locking Plate summary
K2603902026-03-17GM Dos Reis Industria e Comercio Ltda.Super Upper Limbs Versalock Plating System summary
K2539162026-03-16Medartis AGAPTUS Shoulder Proximal Humerus System, PentaLock 3. summary
K2539062026-03-11Newclip TechnicsXpert Hand summary
K2540932026-03-10Synthes GmbHDePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating summary
K2600692026-03-09Synthes GmbHDePuy Synthes VOLT™ Proximal Tibia 3.5 Plating Syste summary
K2603532026-03-03Arthrex, Inc.Arthrex Humeral Plating System (Anatomic Humeral Pla summary
K2540542026-03-02Synthes GmbHVOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Cal summary
K2542492026-02-27Hankil Tech Medical Co., Ltd.HKT Anatomical Locking Trauma System summary
K2521662026-02-26Globus Medical, Inc.RIB LINK™ Fixation System summary
K2536602026-02-20KLS-Martin L.P.KLS Martin Pure Pectus System summary
K2541622026-02-20KLS Martin L.P.KLS Martin Ixos System summary
K2517322026-02-12Met One Technologies, LLCWrist Fracture System summary
K2537132026-01-21Arthrex, Inc.Arthrex Variable Angle (VA) Proximal Tibia Plating S summary
K2540022026-01-15TriMed, Inc.TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Vo summary
K2528072026-01-12Arthrex, Inc.Arthrex Anatomic Lapidus Plates and I-Beam Lapidus P summary
K2531782026-01-06Crossroads Extremity SystemsTRILEAP Plating System summary
K2510502025-12-19Gm Dos Reis Industria E ComercioPectus Versa System summary
K2521912025-12-17Bonebridge AGBRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal summary
K2528972025-12-11A Plus Biotechnology Co., Ltd.APS Osteotomy Fixation System (0945-1302-xx /4.5mm C summary
K2509882025-12-11KLS-Martin L.P.KLS Martin Pure Pectus System summary
K2529972025-12-11Hyperflex MedicalHyperFlex® Bunion Correction System summary
K2526612025-11-19Fusion Innovations, LLCSternaFuse Ti Fixation System summary
K2534232025-11-18Nvision Biomedical Technologies, Inc.ToeJack MIS Bunion System summary
K2508652025-11-14KLS-Martin L.P.KLS Martin IPS Forearm System summary
K2529492025-11-13Skeletal Dynamics, Inc.Geminus Volar Distal Radius Plating System summary
K2529592025-11-12Intrauma S.P.AWRISTAR MultiAx Distal Radius Kit summary
K2533002025-10-28Bodycad Laboratories, Inc.Fine Osteotomy™ summary
K2526002025-10-09OrthoPediatrics Corp.Pediatric Plating Platform I Small-Mini summary
K2518922025-09-08Maxxos Medical GmbHMAXXOS P.A.C.E. Foot & Ankle Plating System summary
K2523562025-08-21Acumed, LLCThe Acumed Wrist Fixation System - 2.4mm Screws summary
K2509232025-08-21Bodycad Laboratories, Inc.Fine Osteotomy™ summary
K2511352025-08-21Treace Medical ConceptsTreace Medical Concepts (TMC) Implant Fixation Syste summary
K2520612025-08-20TriMed, Inc.Distal Xtremities System summary
K2511612025-08-18Globus Medical, Inc.ANTHEM® Fracture System summary
K2519132025-08-16OsteoCentric TechnologiesOsteoCentric® UnifiMI® TCS Plating System summary
K2506202025-08-15KLS Martin L.P.KLS Martin Ixos System summary
K2513612025-07-30Tyber Medical, LLCTyber Medical Distal Radius Plating System summary
K2516202025-07-25Zimmer BiometA.L.P.S. Proximal Humerus Plating System summary
K2509522025-07-18Paragon 28, Inc.Baby Gorilla®/Gorilla® Plating System summary
K2511322025-07-14Acumed, LLCThe Acumed Wrist Fixation System - Plates; The Acume summary
K2519452025-07-10TriMed, Inc.TriMed Total Wrist Fusion System (Total Wrist Fusion summary
K2429882025-06-27Genostis AFGenostis Osteosynthesis System summary
K2509292025-06-26TriMed, Inc.TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compr summary
K2432752025-06-26Exactech, Inc.Equinoxe® Scapula Fracture System summary
K2512962025-06-18Acumed, LLCThe Acumed Wrist Fixation System summary
K2509332025-06-11Bonebridge AGLORRAINE 2.5/3.5mm Distal Humerus System summary
K2433682025-06-04Medifield Medical Co., Ltd.Montblanc Plate System summary
K2427512025-05-30Jeil Medical CorporationARIX Pectus Bar System summary
K2434692025-05-29Osteonic Co., Ltd.SIGNEX summary
K2509352025-05-22TriMed, Inc.TriMed Fifth Metatarsal System (Fifth Metatarsal Pla summary
K2439632025-04-29OrthoPediatrics Corp.Pediatric Plating Platform Hip summary
K2508922025-04-25L&K BIOMED Co., Ltd.CastleLoc Pectus Bar System summary
K2429732025-04-24Canwell Medical Co., Ltd.CanMINI Hand and Foot System summary
K2501552025-04-23Newclip TechnicsXpert Knee summary
K2509482025-04-08TriMed, Inc.TriMed Fusion Cup System summary
K2439952025-03-26Arthrex, Inc.Arthrex Humeral Plating System and Cerclage Button summary
K2439872025-03-19TriMed, Inc.TriMed Elbow and Forearm System summary
K2424862025-03-19Tyber Medical, LLCTyber Medical Anatomical Plating System summary
K2439992025-03-19TriMed, Inc.TriMed Ankle Fixation System summary
K2504942025-03-18OsteoCentric TechnologiesThe OsteoCentric Bone Plate and Screw System summary
K2504982025-03-17Orthonovis, Inc.BPS Wrist Fracture System summary
K2436102025-03-07Medartis AGAPTUS Hand System; APTUS Elbow Dorsal Olecranon summary
K2433572025-02-27L&K BIOMED Co., Ltd.CastleLoc Pectus Bar System summary
K2416662025-02-19Smith & NephewEVOS Pelvic and Acetabular System summary
K2437612025-02-19Biomet OrthopedicsA.L.P.S. Small Fragment Plating System summary
K2409582025-02-10Hebei Ruihe Medical Devices Co., Ltd.Locking Plates and Screws Systems summary
K2500552025-02-06Orthonovis, Inc.BPS - Bone Fragment Fixation Plates, Screws and Wash summary
K2415992025-02-06Signature Orthopaedic Pty , Ltd.Signature Osteosynthesis Plate System summary
K2437402025-01-29GM Dos Reis Industria e Comercio Ltda.Versalock Upper Limb Plating System summary
K2435692025-01-15TriMed, Inc.TriMed Wrist Fixation System (Volar Bearing Plates); summary
K2429392024-12-23Artfx MedicalARTFX Trauma Bone Plate and Screw System summary
K2433082024-12-20Bonebridge AGBonebridge Osteosynthesis Plating System (SALGINA 2. summary
K2434912024-12-11Stryker Leibinger GmbH & Co KGSternalPlate Expansion summary
K2411282024-12-05Tdm Co., Ltd.TDM Plate and Screw System summary
K2430502024-11-26TriMed, Inc.TriMed Posterior Malleolus Fixation System summary
K2419952024-11-26Footbridge MedicalHyperFlex™ Bunion Correction System summary
K2429982024-11-21GM Dos Reis Industria e Comercio Ltda.GMReis Ankle Plating System summary
K2425962024-11-21GM Dos Reis Industria e Comercio Ltda.Versalock Mini and Micro Plating System summary
K2420792024-11-14Arthrex, Inc.Arthrex Elbow Fracture Plating System summary
K2424362024-11-14Skeletal Dynamics, Inc.Proximal Humerus Fixation System summary
K2428142024-11-14Microware Precision Co., Ltd.Tandry Q-Locking Plate System summary
K2403882024-11-014Web Medical, Inc.Osteotomy Truss System (OTS) summary
K2423992024-10-31Bonebridge AGBonebridge Osteosynthesis Plating System summary
K2429952024-10-23The Orthopaedic Implant CompanyOIC Small / Mini Fragment Plate System summary
K2425542024-10-21Arthrex, Inc.Arthrex VAL and VAL KreuLock™ Compression Screw Syst summary
K2401812024-10-09Auxein Medical Pvt., Ltd.Clavicle and Scapula System summary
K2424452024-10-06Stryker GmbHPangea Platform; Pangea Femur Plating System; Pangea summary
K2423432024-10-04Orthonovis, Inc.BPS Wrist Fracture System summary
K2418152024-09-26Skeletal Dynamics, Inc.Protean Fragment Plating System summary
K2417092024-09-19Biomet MicrofixationPectus Blu Support Bar System summary
K2419422024-09-17TriMed, Inc.TriMed Bridge Plates summary
K2413562024-09-05Bodycad Laboratories, Inc.Fine Osteotomy™ summary
K2404872024-09-03Smith & NephewEVOS Patella Plates summary

41 more not listed.

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