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
+6K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+6K220650TriMed Ripcord DeviceTriMed, Inc.202211
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+6K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+6K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+6K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+6K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+6K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+6K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+6K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+6K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+6K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+6K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+6K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+6K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+6K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+6K180759SECULOK™ Suture AnchorU&I Corporation20180—
+6K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+6K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+6K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K172008ARIX Humerus SystemJeil Medical Corporation20173—
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+6K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+6K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+6K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+6K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+6K161746ARIX Hand SystemJeil Medical Corporation20161—
+6K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+6K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+6K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+6K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+6K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+6K143092Tensyn PlugDallen Medical, Inc.20151—
+6K143139Arthrex Fracture SystemArthrex, Inc.20151—
+6K141420FastforwardMedShape, Inc.20145—
+6K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+6K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+6K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+6K133939Modified Distal Radius Plating SystemBiomet2014112
+6K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+6K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+6K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+6K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+6K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+6K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+6K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+6K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+6K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+6K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+6K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+6K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+6K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+6K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+6K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+6K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+6K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+6K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+6K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+6K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+6K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+6K090107Mini TightropeArthrex, Inc.200921—
+6K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…DePuy Orthopaedics, Inc.200918—
+6K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+6K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+6K082078Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc.200847
+6K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+6K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc.20086—
+6K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+6K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+6K060864Multidirectional Threaded PegHand Innovations, LLC200618—
+6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+7K262975Arthrex Beaming SystemArthrex, Inc.20260—
+7K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K253115Lars AcjMovmedix S.A.S.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+7K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+7K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+7K251134RipCordTriMed, Inc.20250—
+7K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+7K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+7K242091Bolo Button SystemFusion Orthopedics20240—