510(k) Report

Devices descending from K010983

385 later devices reach Plla Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073311Osteotrans-OT PinTakiron Co., Ltd.20080—
+1K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC20051—
+1K041288Modification to SmartpinLinvatec Biomaterials, Inc.20042—
+1K031712Inion Otps Biodegradable PinInion, Ltd.2003382—
+2K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+2K133477Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical20149—
+2K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918—
+2K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC20070—
+2K061164ActivapinBioretec, Ltd.200637—
+2K050275Modification to: Inion Otps Biodegradable PinInion, Ltd.200551—
+2K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+3K181180OSSIO™ Pin Product FamilyOSSIO, Ltd.201913—
+3K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+3K173616DIP Arthrodesis SystemIn2bones Sas20180—
+3K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH20170—
+3K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+3K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+3K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+3K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+3K133932Inion FreedompinInion OY20144—
+3K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+3K133950Activapin HT, Fuse Link (Private Labled for Footmind, Inc.)Bioretec, Ltd.20140—
+3K081348Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc.20081—
+3K080879Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm…Bioretec, Ltd.20081—
+3K071863Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)Bioretec, Ltd.20070—
+3K062980ActivascrewBioretec, Ltd.20061—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+4K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+4K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+4K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies20253—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+4K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K211789restor3d Pin ImplantsRestor3D20220—
+4K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+4K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail…OSSIO, Ltd.20215—
+4K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+4K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+4K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+4K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+4K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO, Ltd.20201—
+4K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+4K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+4K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+4K173910Impress SFS SystemCable Fix Medical, LLC20180—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+4K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+4K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+4K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+4K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+4K152710HammerFiX DeviceExtremity Medical, LLC20151—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+4K150359Tensyn PlugDallen Medical, Inc.20150—
+4K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K131850Tensyn BandDallen Medical, Inc.20135—
+4K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+4K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K083070Toggleloc SystemBiomet Sports Medicine2008946
+4K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+4K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+5K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+5K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+5K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+5K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+5K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+5K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+5K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+5K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+5K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K230750OSSIOfiber® Cannulated Trimmable Fixation NailOSSIO, Ltd.20234—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+5K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+5K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211