510(k) Report

Devices descending from K031712

382 later devices reach Inion Otps Biodegradable Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+4K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO, Ltd.20200—
+4K193583Restrata®Acera Surgical, Inc.202011
+4K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+4K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+4K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+4K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+4K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+4K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+4K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+4K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+4K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+4K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+4K143139Arthrex Fracture SystemArthrex, Inc.20151—
+4K141420FastforwardMedShape, Inc.20145—
+4K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+4K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+4K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+4K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+4K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+4K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+4K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+4K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+4K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+4K090107Mini TightropeArthrex, Inc.200921—
+4K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+4K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+4K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+4K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K253115Lars AcjMovmedix S.A.S.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—
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+5K230546SignexOsteonic Co., Ltd.20242—
+5K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K232847SiOxD Wound MatrixSioxmed, LLC20231—
+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—
+5K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+5K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+5K192984APTUS Clavicle SystemMedartis AG20206—
+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—
+5K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+5K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+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
+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—