510(k) Report

Devices descending from K953806

240 later devices reach Synthes (Usa) Midfacial System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112457Leforte System Bone Plate & ScrewArkin Consulting Group201216—
+4K112064Resorb X-GKLS-Martin L.P.20122—
+4K112812Leforte Neuro System Bone PlateJeil Medical Corporation201211—
+4K113109Stryker Resorbable Fixation SystemStryker20113—
+4K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.201178—
+4K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.2011841
+4K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111—
+4K103084Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S20110—
+4K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+4K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+4K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP20062—
+4K061507Sonicweld RX Endobrow FixationKLS-Martin L.P.20060—
+4K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003100—
+5K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants20222—
+5K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—
+5K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+5K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+5K181806ARIX Sternal SystemJeil Medical Corporation20180—
+5K173579Thorecon™ Fixation SystemA & E Medical Corporation20181—
+5K170368Sterile NS SystemJeil Medical Corporation20170—
+5K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+5K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+5K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+5K150965LeForte System IIJeil Medical Corporation20151—
+5K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544—
+5K141644Innovasis Cranial SystemInnovasis, Inc.20140—
+5K142484Sternal Closure SystemJace Medical, LLC20141—
+5K140309CranioplugOssdsign AB20142—
+5K141452Leforte Neuro System Bone Plate and ScrewJeil Medical Corporation20144—
+5K133304RXG Distraction SystemKLS-Martin L.P.20140—
+5K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2014451
+5K131311Arix Foot SystemJeil Medical Corporation20139—
+5K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+5K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246—
+5K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275—
+5K101484Compressyn BandDallen Medical20115—
+5K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+5K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+5K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060—
+6K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+6K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+6K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+6K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K210099Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd.20212—
+6K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+6K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+6K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+6K183172Stryker SternalPlate SystemStryker20191—
+6K181539OSSDSIGN CranioplugOssdsign AB20181—
+6K181607Thorecon Rigid Fixation SystemA & E Medical Corporation201805
+6K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+6K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201643—
+6K161896Biomet Microfixation Sternal Closure SystemBiomet Microfixation20164—
+6K161864ARIX Foot SystemJeil Medical Corporation20165—
+6K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation201543—
+6K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+6K130431Compressyn BandDallen Medical, Inc.20134—
+7K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+7K252251Easymade-TICG Bio Co., Ltd.20260—
+7K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+7K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+7K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.20260—
+7K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+7K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.20240—
+7K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH20240—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K212782SternaLock Sternal Closure SystemBiomet Microfixation20220—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)202040—
+7K182179AdvantageRib Anterior SystemSig Medical Corp.20180—
+7K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation201640—
+7K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201611—
+7K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201513—
+7K133858Tensyn BandDallen Medical, Inc.20143—
+8K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—