510(k) Report

Devices descending from K935448

469 later devices reach Luhr Mini Bone Screw and Z Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+7K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+7K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+7K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K210159IntraLock SystemFusion Orthopedics, LLC20210—
+7K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+7K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+7K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+7K202307Activ FuseNewclip Technics20200—
+7K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+7K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+7K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+7K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+7K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+7K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+7K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K181806ARIX Sternal SystemJeil Medical Corporation20180—
+7K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+7K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K173746Activmotion RangeNewclip Technics20181—
+7K173579Thorecon™ Fixation SystemA & E Medical Corporation20181—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+7K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+7K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+7K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544—
+7K142484Sternal Closure SystemJace Medical, LLC20141—
+7K140309CranioplugOssdsign AB20142—
+7K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2014451
+7K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246—
+7K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275—
+7K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+7K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060—
+8K254280F.A.S.T ScrewSteps Ortho20260—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+8K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+8K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+8K240487EVOS Patella PlatesSmith & Nephew20240—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K241539Activmotion SNewclip Technics20240—
+8K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+8K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+8K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+8K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+8K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+8K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+8K183172Stryker SternalPlate SystemStryker20191—
+8K181539OSSDSIGN CranioplugOssdsign AB20181—
+8K181607Thorecon Rigid Fixation SystemA & E Medical Corporation201805
+8K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201643—
+8K161896Biomet Microfixation Sternal Closure SystemBiomet Microfixation20164—
+8K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation201543—
+8K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+8K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+8K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+9K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+9K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+9K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG20240—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+9K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.20240—
+9K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH20240—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—