510(k) Report

Devices descending from K002334

73 later devices reach Macroporens Craniloc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040080Aesculap Absorbable CraniofixAesculap, Inc.20048—
+1K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp.200363—
+2K130309Rapidflap LS Cranial Flap Fixation SystemBiomet Microfixation20131—
+2K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L20104—
+2K091692Aesculap Peek CraniofixAesculap, Inc.20100—
+2K062857KLS Martin Quick DiscKLS Martin L.P.200662—
+3K221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.20230—
+3K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L20133—
+3K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+4K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+4K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L20240—
+4K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.20200—
+4K160739Cranial COVERNeos Surgery S.L20161—
+4K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+4K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+4K142484Sternal Closure SystemJace Medical, LLC20141—
+4K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+4K101484Compressyn BandDallen Medical20115—
+5K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+5K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+5K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+5K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+5K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+5K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+5K130431Compressyn BandDallen Medical, Inc.20134—
+6K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+6K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+6K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+6K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+6K133858Tensyn BandDallen Medical, Inc.20143—
+7K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+7K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+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—
+7K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K143092Tensyn PlugDallen Medical, Inc.20151—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K150359Tensyn PlugDallen Medical, Inc.20150—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—