510(k) Report

Devices descending from K032228

101 later devices reach Lorenz 2.4 Self Drilling Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.200687—
+1K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003100—
+2K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.201178—
+2K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.2011841
+2K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111—
+2K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+2K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060—
+3K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+3K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+3K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+3K181806ARIX Sternal SystemJeil Medical Corporation20180—
+3K173579Thorecon™ Fixation SystemA & E Medical Corporation20181—
+3K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544—
+3K142484Sternal Closure SystemJace Medical, LLC20141—
+3K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2014451
+3K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+3K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246—
+3K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275—
+3K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+4K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+4K183172Stryker SternalPlate SystemStryker20191—
+4K181607Thorecon Rigid Fixation SystemA & E Medical Corporation201805
+4K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201643—
+4K161896Biomet Microfixation Sternal Closure SystemBiomet Microfixation20164—
+4K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+4K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+4K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation201543—
+4K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+4K101484Compressyn BandDallen Medical20115—
+5K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.20240—
+5K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH20240—
+5K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+5K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K212782SternaLock Sternal Closure SystemBiomet Microfixation20220—
+5K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)202040—
+5K182179AdvantageRib Anterior SystemSig Medical Corp.20180—
+5K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation201640—
+5K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201611—
+5K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201513—
+5K130431Compressyn BandDallen Medical, Inc.20134—
+6K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+6K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K221412ARIX Rib SystemJeil Medical Corporation20221—
+6K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation20168—
+6K133858Tensyn BandDallen Medical, Inc.20143—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K212608RibFix Blu Thoracic Fixation SystemBiomet Microfixation20224—
+7K190409MatrixRIB Fixation SystemDePuy Synthes20193—
+7K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+8K261054RibPlate SystemStryker Leibinger GmbH & Co KG20260—
+8K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.20260—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+8K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC20190—
+8K143092Tensyn PlugDallen Medical, Inc.20151—