510(k) Report

Devices descending from K082807

186 later devices reach Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+3K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc.20230—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K213572JuniOrtho Plating System™Orthofix Srl20220—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+3K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+3K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+3K190430OsteoCentric Bone Plate and Screw SystemOsteocentric Trauma20192—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170727VariAx 2 Compression Plating SystemStryker GmbH20172—
+3K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+3K140769Variax 2 SystemStryker Trauma AG201419—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+4K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+4K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K173135VariAx 2 SystemStryker GmbH201713—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K180500VariAx 2 SystemStryker GmbH201812—
+6K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+7K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+7K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+8K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+8K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+8K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K233919VariAx 2 Distal Radius SystemStryker GmbH20242—