510(k) Report

Devices descending from K143258

211 later devices reach PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+1K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+1K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+1K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+1K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+1K153436LATERAL Spine Truss System4Web, Inc.20165—
+2K2530413d Cage CervicalFims Co., Ltd.20260—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K261067BEE PLIF CageNGMedical GmbH20260—
+2K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+2K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+2K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+2K223326Axiom PSR SystemRestor3D202301
+2K211413BEE PLIF CageNGMedical GmbH20211—
+2K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+2K200429BEE CagesNGMedical GmbH202111—
+2K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+2K200312Tryptik TiSpineart20202—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K1803473d CageFims Co., Ltd.20190—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+2K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+2K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+3K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+3K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+3K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+3K230583Tryptik TiSpineart SA20231—
+3K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+3K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+3K191134IB3D AlifMedicrea International SA20191—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K182608Oyster ACIF CageSilony Medical GmbH20190—
+3K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K250560BEE HANGMedical GmbH20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+4K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210728CONDUIT InstrumentsMedos International SARL20215—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—