510(k) Report

Devices descending from K080401

840 later devices reach Shell Cage, Wave Cage, Loop Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K172065Scarlet AC-TSpineart20172—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250560BEE HANGMedical GmbH20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—