510(k) Report

Devices descending from K946173

155 later devices reach Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+1K203855CoNextions TR Tendon Repair SystemConextions Medical20220—
+1K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.201742—
+1K161638SPEEDTRAP Graft Preparation SystemMedos International SARL20160—
+1K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND…Ethicon, LLC20160—
+1K142484Sternal Closure SystemJace Medical, LLC20141—
+1K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2014451
+1K133356Prolene Polypropylene Nonabsorbable SutureETHICON, Inc.2013421
+1K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+1K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246—
+1K120016Pioneer Sternal Assist Implant SystemPioneer Surgical Technology, Inc.20120—
+1K120177Spinal Elements Cerclage SystemSpinal Elements, Inc.20120—
+1K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.201178—
+1K110789Synthes Sternal Zipfix SystemSynthes (Usa)2011853
+1K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111—
+1K101484Compressyn BandDallen Medical20115—
+1K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L.20090—
+1K063017Aesculap Sternumfix Sternal Closure SystemAesculap, Inc.20061—
+1K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical200242—
+2K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+2K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+2K211613Stern Fix Sternal Stabilization SystemNeos Surgery S.L20221—
+2K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+2K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+2K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+2K193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.20200—
+2K181806ARIX Sternal SystemJeil Medical Corporation20180—
+2K173579Thorecon™ Fixation SystemA & E Medical Corporation20181—
+2K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited.20162—
+2K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+2K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544—
+2K142639StitchKitOrigami Surgical, LLC20140—
+2K130431Compressyn BandDallen Medical, Inc.20134—
+2K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275—
+2K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+2K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+2K053252U-Clip Device, Models B140, B160 and B180Medtronic Vascular20051—
+2K040821Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20040—
+2K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical2003324
+2K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical2003411
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+3K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+3K221795STERN FIX Sternal Stabilization SystemNeos Surgery S.L20220—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+3K183172Stryker SternalPlate SystemStryker20191—
+3K181607Thorecon Rigid Fixation SystemA & E Medical Corporation201805
+3K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited.20171—
+3K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201643—
+3K161896Biomet Microfixation Sternal Closure SystemBiomet Microfixation20164—
+3K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation201543—
+3K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+3K133858Tensyn BandDallen Medical, Inc.20143—
+3K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+3K062821U-Clip DeviceMedtronic Neurosurgery20060—
+3K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050Cardica, Inc.20057—
+3K033324Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd.20047—
+4K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG20240—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.20240—
+4K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH20240—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K231183Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd.20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K212782SternaLock Sternal Closure SystemBiomet Microfixation20220—
+4K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)202040—
+4K182179AdvantageRib Anterior SystemSig Medical Corp.20180—
+4K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+4K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation201640—
+4K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+4K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201611—
+4K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+4K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201513—
+4K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+4K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+4K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+4K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+4K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200751
+4K053524C-Port Distal Anastomosis SystemCardica, Inc.200661
+4K050356Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd.20052—
+4K043115Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd.20045—
+4K041751Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd.20046—
+5K250541Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.20251—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—