510(k) Report

Devices descending from K022325

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151407RECON systemNormed Medizin-Technik GmbH20154—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+1K061808Darco Locking Bone Plate SystemDarco International, Inc.20064103
+1K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004249—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K221395Footmotion Plating SystemNewclip Technics20220—
+2K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K171852DARCO Locking Bone Plate SystemWrightmedicaltechnologyinc20172—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K153340Epic Extremity Plate SystemEpic Extremity, LLC201632
+2K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+2K150520DARCO Locking Bone Plate SystemWrightmedicaltechnologyinc20152—
+2K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K142121Valor Hindfoot Fusion Nail SystemWrightmedicaltechnologyinc20144—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K140876View Plating System,Reduce Fracture Plating System,Bone ScrewIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic2014215
+2K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+2K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+2K130510Arthrex Compression PlatesArthrex, Inc.20138—
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+2K120359Ortholoc 3DI Hallux SystemWrightmedicaltechnologyinc2012842
+2K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+2K102201Contours Lapidus Plating SystemOrthofix, Inc.20100—
+2K102688Merete Locking Bone Plate System IIMerete Medical GmbH20100—
+2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+2K092528Biomet Forerunner Locking Plate SystemBiomet Trauma (Aka Ebi, Lp)201053—
+2K090063Merete Locking Bone Plate SystemMerete Medical, Inc.2009241—
+2K083447Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50Memometal Technologies200992—
+2K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008256—
+2K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+2K071105Osteomed Calcaneal Plate and Screw Fixation SystemOsteomed LP20079—
+2K052614Low Profile Plate and Screw SystemArthrex, Inc.2005245—
+2K052152B-Bop PlateNew Deal, S.A.20051—
+2K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+3K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+3K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+3K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+3K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+3K213567Medline UNITE Calcaneal Fracture Plating SystemMedline Industries, LP20221—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+3K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K190388RIVAL View Plating Systems and Reduce Fracture Plating SystemsOrthofix Srl20190—
+3K190670ORTHOLOC™ 2 Lapidus with Rotation SystemWrightmedicaltechnologyinc20190—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K172148Anchorage Bone Plating SystemStryker GmbH20184—
+3K172441EPIC Extremity Fracture Plate SystemEpic Extremity, LLC20171—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K171510Footmotion Plating SystemNewclip Technics20171—
+3K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K163293Colink™ Plating SystemIn2bones USA, LLC2017212
+3K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—