510(k) Report

Devices descending from K070946

132 later devices reach Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182492Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC20186—
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+1K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+1K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.201080—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K252949Geminus Volar Distal Radius Plating SystemSkeletal Dynamics, Inc.20250—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+2K232144Sterile Products of the APTUS SystemMedartis AG20233—
+2K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K213214Xpert WristNewclip Technics20210—
+2K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K161861APTUS® Coronoid 2.0Medartis AG20170—
+2K151468ARIX Wrist SystemJeil Medical Corporation20167—
+2K133974Variax Distal Radius Plating SystemStryker Leibinger GmbH201420—
+2K132502Variax 2 SystemStryker Trauma AG201321—
+2K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+2K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201156—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+3K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K241539Activmotion SNewclip Technics20240—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K172008ARIX Humerus SystemJeil Medical Corporation20173—
+3K170705ARIX Wrist SystemJeil Medical Corporation20172—
+3K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+3K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+3K140769Variax 2 SystemStryker Trauma AG201419—
+3K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+3K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K254215Arthrex Beaming SystemArthrex, Inc.20261—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+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—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K230938ARIX Humerus SystemJeil Medical Corporation20230—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K173135VariAx 2 SystemStryker GmbH201713—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—