510(k) Report

Devices descending from K061808

410 later devices reach Darco Locking Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+3K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253906Xpert HandNewclip Technics20260—
+3K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+3K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+3K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+3K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+3K251709MedCAD® AccuStride™ SystemMedcad20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K242988Genostis Osteosynthesis SystemGenostis AF20250—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K243469SignexOsteonic Co., Ltd.20250—
+3K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+3K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+3K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+3K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+3K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+3K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+3K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+3K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+3K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K211435PAO Cortical ScrewMedacta International S.A.20210—
+3K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+3K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+3K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+3K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+3K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+3K191636APTUS Foot SystemMedartis AG20190—
+3K191009Arsenal Plating SystemTrilliant Surgical20192—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+3K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+3K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K162380Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd.20170—