510(k) Report

Devices descending from K963798

756 later devices reach Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K133974Variax Distal Radius Plating SystemStryker Leibinger GmbH201420—
+4K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+4K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+4K132769Acumed Hand Plating SystemAcumed, LLC20147—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+4K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+4K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+4K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+4K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+4K111447Zimmer Periarticular ScrewsZimmer, Inc.201114
+4K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201156—
+4K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+4K103332Aptus Ulna PlatesMedartis AG201171—
+4K102537Aptus 1.5 TrilockMedartis AG201019—
+4K0724234.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous…DePuy Orthopaedics, Inc.20074—
+4K062498Profyle SystemHowmedica Osteonics Corp.2006811
+4K061917Distal Radius Locking Plating SystemNewclip Technics20066—
+4K050121Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc.200527—
+4K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003615—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+5K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241695Extremity All Suture SystemField Orthopaedics20240—
+5K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+5K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+5K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+5K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+5K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+5K201656ARIX Elbow SystemJeil Medical Corporation20200—
+5K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+5K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+5K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K180500VariAx 2 SystemStryker GmbH201812—
+5K170972Apex Tibial Nailing SystemOrthoxel20171—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K161861APTUS® Coronoid 2.0Medartis AG20170—
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K151468ARIX Wrist SystemJeil Medical Corporation20167—
+5K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+5K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+5K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+5K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+5K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+5K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+5K131566Arix Hand SystemJeil Medical Corporation20138—
+5K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+5K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+5K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+5K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+5K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+5K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc.20103—
+5K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+5K070906Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc.20071421
+5K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20056061
+5K042437Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC20047—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K254215Arthrex Beaming SystemArthrex, Inc.20261—
+6K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+6K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+6K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—