510(k) Report

Devices descending from K012001

337 later devices reach Smartscrew through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K251134RipCordTriMed, Inc.20250—
+5K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+5K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+5K242091Bolo Button SystemFusion Orthopedics20240—
+5K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+5K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+5K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+5K230546SignexOsteonic Co., Ltd.20242—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+5K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+5K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+5K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+5K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+5K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+5K212739ActiFlipParcus Medical, LLC20210—
+5K211049Tigon Medical Button SystemTigon Medical20210—
+5K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+5K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+5K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+5K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+5K192984APTUS Clavicle SystemMedartis AG20206—
+5K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+5K191426FiberTak ButtonArthrex, Inc.20190—
+5K190143LARS AC Band DeviceCorin USA20191—
+5K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+5K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+5K191204Infinity Fixation SystemConmed Corporation20190—
+5K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+5K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+5K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+5K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+5K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+5K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+5K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+5K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+5K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+5K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+5K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+5K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+5K133275Mini TightropeArthrex, Inc.201411—
+5K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+5K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+5K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+5K111032CMC Cable FixInstratek, Inc.20112—
+5K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+5K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+6K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K254182AsterOsteonic Co., Ltd.20260—
+6K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+6K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+6K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+6K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+6K243469SignexOsteonic Co., Ltd.20250—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+6K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+6K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+6K220966SinefixBAAT Medical Products B.V.20231—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+6K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+6K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+6K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+6K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+6K202307Activ FuseNewclip Technics20200—
+6K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+6K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—