510(k) Report

Devices descending from K971297

140 later devices reach Centre-Drive Drill-Free Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+1K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+1K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+1K042573KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.20044—
+1K033483KLS-Martin Ortho Anchorage SystemKLS-Martin L.P.200418—
+1K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20035—
+1K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc.20027—
+1K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002117—
+1K992106Modus System Self-Drilling ScrewsMedartis AG19990—
+2K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+2K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+2K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation201251
+2K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+2K083432Drill Free MMF ScrewKLS Martin L.P.20093—
+2K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+2K063473Synthes Orthodontic Bone Anchor SystemSynthes (Usa)20070—
+2K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.200687—
+2K061397Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…Ace Surgical Supply Co., Inc.20066—
+2K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger20044—
+2K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003101—
+2K031751Rapidfire Self Drilling ScrewsWalter Lorenz Surgical, Inc.200301
+2K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030—
+3K233721KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.20240—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+3K170697GBR systemSurgident20182—
+3K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+3K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+3K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+3K142484Sternal Closure SystemJace Medical, LLC20141—
+3K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+3K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+3K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.201178—
+3K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.2011841
+3K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111—
+3K101484Compressyn BandDallen Medical20115—
+3K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link20091—
+3K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc.20085—
+3K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+3K051798Osteomed Orthodontic Anchor Plating SystemOsteomed LP20060—
+3K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003100—
+4K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+4K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+4K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+4K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+4K222367Save GBRDentis Co., Ltd.20230—
+4K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+4K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+4K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+4K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+4K181806ARIX Sternal SystemJeil Medical Corporation20180—
+4K173623Anchor plateBiomaterials Korea, Inc.20180—
+4K173579Thorecon™ Fixation SystemA & E Medical Corporation20181—
+4K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+4K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544—
+4K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2014451
+4K130431Compressyn BandDallen Medical, Inc.20134—
+4K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246—
+4K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275—
+4K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+4K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+4K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+4K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060—
+5K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+5K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+5K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+5K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+5K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+5K183172Stryker SternalPlate SystemStryker20191—
+5K181607Thorecon Rigid Fixation SystemA & E Medical Corporation201805
+5K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201643—
+5K161896Biomet Microfixation Sternal Closure SystemBiomet Microfixation20164—
+5K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation201543—
+5K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+5K133858Tensyn BandDallen Medical, Inc.20143—
+5K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+6K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+6K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+6K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.20240—
+6K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K212782SternaLock Sternal Closure SystemBiomet Microfixation20220—
+6K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)202040—
+6K182179AdvantageRib Anterior SystemSig Medical Corp.20180—
+6K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation201640—
+6K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201611—
+6K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201513—
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—