510(k) Report

Devices descending from K961608

577 later devices reach Synthes (U.S.a.) Polypin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031712Inion Otps Biodegradable PinInion, Ltd.2003382—
+1K993074Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd.19997—
+1K972919Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift ScrewBionx Implants, Inc.199887—
+1K974876Bionx Distal Radius ScrewBionx Implants, Inc.1998419—
+2K133477Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical20149—
+2K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918—
+2K073311Osteotrans-OT PinTakiron Co., Ltd.20080—
+2K070178Aesculap Resorbable Pin, Model FR735Aesculap Implant System, Inc.20070—
+2K061164ActivapinBioretec, Ltd.200637—
+2K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050—
+2K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC20051—
+2K050275Modification to: Inion Otps Biodegradable PinInion, Ltd.200551—
+2K041288Modification to SmartpinLinvatec Biomaterials, Inc.20042—
+2K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd.20041—
+2K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+2K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd.20033—
+2K023022Nugen FX ScrewBionx Implants, Inc.20022—
+2K020222Wisorb Malleolar ScrewCambridge Scientific, Inc.20022—
+2K020819Distal Radius Plating SystemBiomet, Inc.20021—
+2K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc.20014—
+2K013057Biocuff,C, Models 236018, 236028, 236036Bionx Implants, Inc.200179—
+2K012001SmartscrewBionx Implants, Ltd.2001337—
+2K0120001.5MM Bone Fixation KitBionx Implants, Ltd.20015—
+2K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999413—
+2K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.199886—
+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—
+3K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+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—
+3K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080—
+3K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC20070—
+3K071863Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)Bioretec, Ltd.20070—
+3K062980ActivascrewBioretec, Ltd.20061—
+3K052624Inion Otps Biodegradable Distal Radius PlateInion, Ltd.20050—
+3K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc.200501
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+3K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—
+3K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd.20041—
+3K040265Little Grafter ScrewBiocomposites, Ltd.20041—
+3K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003333—
+3K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+3K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+3K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+3K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+3K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+3K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.19996—
+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—
+4K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+4K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+4K113109Stryker Resorbable Fixation SystemStryker20113—