510(k) Report

Devices descending from K900138

137 later devices reach Motech Titanium Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+1K020853Nuvasive MeshNuvasive, Inc.20020—
+1K990345Rabea Device, Model PxxxxxxSignus Medizintechnik GmbH199946—
+1K983766Synthes SynmeshSynthes (Usa)1998114
+1K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces199884—
+2K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K021788NBD Cement Restrictor DeviceNew Business Development, LLC20020—
+2K021719Fortitude Cement RestrictorSpinal Concepts, Inc.20026—
+2K020836Rabea Cement RestrictorSignus Medical, LLC20024—
+2K020344RPX Titanium Cemnt RestrictorSulzer Spine-Tech200233—
+2K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+2K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+2K012462Theken Large Cement RestrictorTheken Surgical,Llc20010—
+2K012278Theken Small Cement RestrictorTheken Surgical,Llc20010—
+2K012413Macropore FX, PS, NS, LPMacropore Biosurgery, Inc.20010—
+2K992905Codman Craniosorb Absorbable Fixation SystemCodman & Shurtleff, Inc.20003—
+2K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K113109Stryker Resorbable Fixation SystemStryker20113—
+3K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+3K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+3K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+3K060132Spinal Usa Cement Restrictor SystemSpinal USA20060—
+3K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp20050—
+3K051607Novaspine Cement Restrictor NSCRNovaspine, LLC20050—
+3K052367Scient'x Cement RestrictorScient'X20051—
+3K051236Resorb-X SFKLS-Martin L.P.20056—
+3K041583Peek Cement Restrictor X-BoxInnovasis, Inc.20040—
+3K033953Optimesh 500E Cement RestrictorSpineology, Inc.20040—
+3K031837Modification to Fortitude Cement RestrictorSpinal Concepts, Inc.20035—
+3K022615Centerpulse, Spine-Tech Division Cement RestrictorCenterpulse Spine-Tech, Inc.200232—
+4K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+4K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+4K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants20222—
+4K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson201501
+4K121606Resorb-X GKLS-Martin L.P.20130—
+4K112064Resorb X-GKLS-Martin L.P.20122—
+4K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+4K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+4K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+4K061507Sonicweld RX Endobrow FixationKLS-Martin L.P.20060—
+5K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+5K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+5K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+5K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+5K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+5K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+5K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K142484Sternal Closure SystemJace Medical, LLC20141—
+5K133304RXG Distraction SystemKLS-Martin L.P.20140—
+5K131636Polarus ConnectAcumed, LLC20130—
+5K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+5K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+5K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+5K101484Compressyn BandDallen Medical20115—
+5K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+5K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+5K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+6K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+6K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+6K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+6K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+6K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+6K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+6K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+6K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+6K160995NEOVIEW Plating SystemIn2bones Sas201624
+6K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+6K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+6K130431Compressyn BandDallen Medical, Inc.20134—
+6K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+6K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+6K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+7K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+7K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+7K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+7K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+7K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+7K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K163589SIGN IM NailSign Fracture Care International20170—
+7K133858Tensyn BandDallen Medical, Inc.20143—
+8K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+8K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+8K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—