510(k) Report

Devices descending from K962616

1,063 later devices reach Synthes Dorsal Distal Radius Plate (DDRP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+8K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+8K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+8K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+8K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+8K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+8K100944Clavicle Locking Plate SystemNewclip Technics20109—
+8K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+8K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+8K091156Trimed Sterile ProductTriMed, Inc.20090—
+8K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+8K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+9K262649Alians ForearmNewclip Technics20260—
+9K254280F.A.S.T ScrewSteps Ortho20260—
+9K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+9K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+9K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+9K254176SinefixBAAT Medical Products B.V.20260—
+9K260405FiberTape ButtonArthrex, Inc.20260—
+9K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+9K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+9K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+9K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+9K250155Xpert KneeNewclip Technics20250—
+9K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+9K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+9K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+9K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+9K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+9K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+9K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K233659Suture WingOsteonic Co., Ltd.20230—
+9K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+9K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+9K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+9K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+9K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+9K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+9K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+9K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+9K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+9K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+9K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+9K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+9K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+9K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+9K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+9K213572JuniOrtho Plating System™Orthofix Srl20220—
+9K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+9K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+9K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+9K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+9K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+9K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+9K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+9K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+9K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+9K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+9K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+9K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+9K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+9K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+9K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+9K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+9K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+9K183331Parcus GFS BTBParcus Medical, LLC20193—
+9K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+9K172921Stryker Self-Punching ICONIXStryker20170—
+9K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+9K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+9K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+9K170310Alians Clavicle rangeNewclip Technics20170—
+9K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+9K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+9K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+9K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+9K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+9K160655OrthoButton CLRiverpoint Medical20169—
+9K153379AxSOS 3TiStryker GmbH201625—
+9K152711Parcus GFS NakedParcus Medical, LLC20154—
+9K151407RECON systemNormed Medizin-Technik GmbH20154—
+9K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+9K150626Rush Medullary PinsZimmer, Inc.20150—
+9K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+9K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+9K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+9K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+9K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+9K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+9K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+9K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+9K124027Monster Screw SystemApogee Orthosolutions201341—
+9K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+9K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+9K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+9K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+9K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—