510(k) Report

Devices descending from K961608

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K083070Toggleloc SystemBiomet Sports Medicine2008946
+4K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+4K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+4K081392Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinBioretec, Ltd.20082—
+4K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+4K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+4K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd.20063—
+4K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+4K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+4K051236Resorb-X SFKLS-Martin L.P.20056—
+4K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+4K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+5K261057ActivaScrew™ Cannulated COMBioretec, Ltd.20260—
+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—
+5K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+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—
+5K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+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
+5K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants20222—
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+5K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+5K203105Inion CompressOn ScrewInion OY20210—
+5K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+5K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO, Ltd.20200—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+5K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+5K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+5K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+5K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+5K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+5K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+5K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+5K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+5K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+5K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+5K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson201501
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K143139Arthrex Fracture SystemArthrex, Inc.20151—
+5K141420FastforwardMedShape, Inc.20145—
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+5K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+5K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+5K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+5K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+5K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+5K121606Resorb-X GKLS-Martin L.P.20130—
+5K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+5K112064Resorb X-GKLS-Martin L.P.20122—
+5K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+5K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+5K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+5K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+5K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+5K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+5K090107Mini TightropeArthrex, Inc.200921—
+5K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+5K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+5K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+5K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+5K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+5K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+5K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+5K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+5K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+5K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—