510(k) Report

Devices descending from K982732

749 later devices reach Synthes (Usa) Distal Radius Plate System (DRPS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201156—
+3K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+3K103332Aptus Ulna PlatesMedartis AG201171—
+3K102537Aptus 1.5 TrilockMedartis AG201019—
+3K0724234.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous…DePuy Orthopaedics, Inc.20074—
+3K062498Profyle SystemHowmedica Osteonics Corp.2006811
+3K061917Distal Radius Locking Plating SystemNewclip Technics20066—
+3K050121Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc.200527—
+3K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003615—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K241695Extremity All Suture SystemField Orthopaedics20240—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+4K201656ARIX Elbow SystemJeil Medical Corporation20200—
+4K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+4K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+4K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K180500VariAx 2 SystemStryker GmbH201812—
+4K170972Apex Tibial Nailing SystemOrthoxel20171—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K161861APTUS® Coronoid 2.0Medartis AG20170—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K151468ARIX Wrist SystemJeil Medical Corporation20167—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+4K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+4K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+4K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+4K131566Arix Hand SystemJeil Medical Corporation20138—
+4K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+4K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+4K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+4K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+4K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+4K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc.20103—
+4K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+4K070906Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc.20071421
+4K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20056061
+4K042437Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC20047—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K254215Arthrex Beaming SystemArthrex, Inc.20261—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+5K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—