510(k) Report

Devices descending from K974555

457 later devices reach Synthes 2.0 MM Locking Plate System (2.0 LPS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K113567Synthes Matrixmadible Plate and Screw SystemSynthes, Inc.20124—
+1K071612Modus Trilock 2.0/2.3/2.5Medartis AG20070—
+1K032520Ortrautek Trauma SystemTekka20030—
+1K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003435—
+1K031989Ortrautek Orthognathic SystemTekka20035—
+1K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003444—
+2K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+2K180962KLS Martin Individual Patient SolutionsKLS-Martin L.P.20180—
+2K163579KLS Martin Individual Patient SolutionsKLS Martin L.P.20179—
+2K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+2K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+2K090522Osteomed Hand Plate and Screw Fixation SystemOsteomed LP200915—
+2K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+2K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+2K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004360—
+3K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+3K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+3K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K191028KLS Martin Individual Patient SolutionsKLS-Martin L.P.20197—
+3K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+3K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+3K143338Argulated Locking PlatesOsteomed LP20150—
+3K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+3K141489Linos Moh Hand Plating SystemKLS Martin L.P.20143—
+3K132769Acumed Hand Plating SystemAcumed, LLC20147—
+3K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+3K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+3K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+3K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+3K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+3K050868MaxlockOrthohelix Surgical Designs, Inc.2005343—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad20230—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K210731KLS Martin Individual Patient SolutionsKLS-Martin L.P.20223—
+4K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S20211—
+4K170697GBR systemSurgident20182—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K170124Level One Hand Plating SystemKLS Martin L.P.20172—
+4K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+4K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+4K142484Sternal Closure SystemJace Medical, LLC20141—
+4K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+4K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+4K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+4K101484Compressyn BandDallen Medical20115—
+4K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+5K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.20260—
+5K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+5K232350Stryker Facial iD SystemStryker Craniomaxillofacial20240—
+5K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+5K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+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—
+5K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+5K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K130431Compressyn BandDallen Medical, Inc.20134—
+5K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+5K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+5K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+5K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+5K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+6K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+6K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+6K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+6K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+6K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+6K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+6K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+6K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+6K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+6K200062Foot and Ankle SystemLeith Medical, LLC20210—
+6K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+6K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+6K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+6K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+6K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—