510(k) Report

Devices descending from K922308

85 later devices reach Tilghman Titanium Mesh Skeletal Orbit Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces199884—
+2K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+2K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+2K012413Macropore FX, PS, NS, LPMacropore Biosurgery, Inc.20010—
+2K992905Codman Craniosorb Absorbable Fixation SystemCodman & Shurtleff, Inc.20003—
+2K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+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—
+3K051236Resorb-X SFKLS-Martin L.P.20056—
+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—
+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—
+5K142484Sternal Closure SystemJace Medical, LLC20141—
+5K133304RXG Distraction SystemKLS-Martin L.P.20140—
+5K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+5K101484Compressyn BandDallen Medical20115—
+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—
+6K130431Compressyn BandDallen Medical, Inc.20134—
+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—
+7K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+7K133858Tensyn BandDallen Medical, Inc.20143—
+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—
+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—
+8K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K143092Tensyn PlugDallen Medical, Inc.20151—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K150359Tensyn PlugDallen Medical, Inc.20150—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K242517ProAM ACDF SystemPro Surgical, Inc.20240—