510(k) Report

Devices descending from K031302

911 later devices reach Sustain Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K200429BEE CagesNGMedical GmbH202111—
+7K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+7K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+7K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+7K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+7K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+7K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+7K200312Tryptik TiSpineart20202—
+7K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K190721LongBow TiLife Spine, Inc.20190—
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+7K183407Triton CageMedyssey USA, Inc.20190—
+7K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K183259Idys™ TLIF TiVacClariance, Sas20191—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+7K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+7K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K173128Alamo® CAlliance Partners, LLC20182—
+7K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+7K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+7K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+7K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+7K172419Velofix™ TLIF CageU&I Corporation20172—
+7K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+7K172424Velofix™ SA Cervical CageU&I Corporation201751
+7K172083Idys™ ALIF SystemClariance, Sas20177—
+7K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+7K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+7K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+7K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+7K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+7K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+7K153665Prow Fusion-LNlt Spine, Ltd.20160—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+7K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+7K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+7K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+7K141942Midline II TICentinel Spine, Inc.2014459—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+7K1421124WEB Spinal Implant Products4Web, Inc.201433—
+7K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+7K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+7K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+8K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261430TruLift Expandable SystemLife Spine, Inc.20260—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+8K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+8K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223494CD Horizon Spinal SystemMedtronic202317—