510(k) Report

Devices descending from K961522

439 later devices reach Kirschner Wire (K-Wire) and Steinmann Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K141420FastforwardMedShape, Inc.20145—
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+5K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+5K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+5K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+5K140328CMC Mini TightropeArthrex, Inc.20146—
+5K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+5K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+5K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+5K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+5K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+5K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+5K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+5K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+5K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+5K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+5K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K253115Lars AcjMovmedix S.A.S.20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K251134RipCordTriMed, Inc.20250—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+6K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+6K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+6K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+6K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K242091Bolo Button SystemFusion Orthopedics20240—
+6K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K230546SignexOsteonic Co., Ltd.20242—
+6K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+6K231857Arthrex TightRope IIArthrex, Inc.20234—
+6K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+6K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+6K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+6K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+6K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+6K221354Arthrex SutureTapeArthrex, Inc.20220—
+6K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+6K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+6K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+6K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K212739ActiFlipParcus Medical, LLC20210—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+6K193575Arthrex SutureTapeArthrex, Inc.20201—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+6K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+6K192984APTUS Clavicle SystemMedartis AG20206—
+6K190143LARS AC Band DeviceCorin USA20191—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+6K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+6K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+6K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173278ToggleLoc SystemBiomet, Inc.20183—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+6K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—
+6K162198GFS UltimateParcus Medical, LLC20168—
+6K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+6K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+6K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+6K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+6K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+6K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+6K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+6K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+6K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+6K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—