510(k) Report

Devices descending from K022325

521 later devices reach Normed Titanium Osteotomy Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K161448Footmotion Plating SystemNewclip Technics20165—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+3K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+3K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+3K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+3K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+3K151277Airlock® osteosynthesis plate systemNovastep20152—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+3K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+3K142581APTUS Foot SystemMedartis AG201522—
+3K143523Airlock osteosynthesis plate systemNovastep20154—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+3K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+3K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+3K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+3K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K142135Reduce Fracture Plating System Line ExtensionIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic201405
+3K140376Variax 2 SystemStryker Trauma AG201423—
+3K132594Crosscheck Plating SystemSolana Surgical, LLC20132321
+3K131445Osteomed Extremilock Foot Plating SystemOsteomed LP20138—
+3K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+3K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+3K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+3K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+3K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+3K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+3K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+3K103705Low Profile ScrewsArthrex, Inc.2011219—
+3K100721Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd.201013—
+3K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+3K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+3K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+3K063831Basal Dorsal PlatesNewdeal Sas20070—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253906Xpert HandNewclip Technics20260—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K251709MedCAD® AccuStride™ SystemMedcad20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242988Genostis Osteosynthesis SystemGenostis AF20250—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+4K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+4K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+4K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—