510(k) Report

Devices descending from K990120

221 later devices reach Modification of Depuy Ace Timax Medial Pilon Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242091Bolo Button SystemFusion Orthopedics20240—
+5K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+5K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+5K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+5K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+5K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+5K221354Arthrex SutureTapeArthrex, Inc.20220—
+5K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+5K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+5K212739ActiFlipParcus Medical, LLC20210—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+5K193575Arthrex SutureTapeArthrex, Inc.20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+5K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+5K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—
+5K162198GFS UltimateParcus Medical, LLC20168—
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+5K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+5K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+5K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+5K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+5K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+6K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+6K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+6K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K220966SinefixBAAT Medical Products B.V.20231—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+6K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+6K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+6K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+6K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+6K183331Parcus GFS BTBParcus Medical, LLC20193—
+6K160655OrthoButton CLRiverpoint Medical20169—
+6K152711Parcus GFS NakedParcus Medical, LLC20154—
+6K150359Tensyn PlugDallen Medical, Inc.20150—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K254176SinefixBAAT Medical Products B.V.20260—
+7K253538TeKBrace Knotless AnchorTheramicro20260—
+7K253695LigaMendRiverpoint Medical, LLC20260—
+7K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+7K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+7K243988RootMend MRRRiverpoint Medical, LLC20250—
+7K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+7K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—