510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K192117Small VBR™Ulrich GmbH & Co. KG20196—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K183407Triton CageMedyssey USA, Inc.20190—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+4K181818Scarlet AL-TSpineart201864—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+4K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K140348Interbody CageEisertech, LLC2015235—
+4K143490VERTA Corpectomy CageCamber Spine20151—
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142016CAPRIK2m, Inc.201412—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K124034Mectalif AnteriorMedacta International201311—
+4K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+4K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+4K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012322—
+4K111294Santorini Spinal SystemK2m, Inc.201218—
+4K112429Giza (R) Vertebral Body ReplacementEden Spine, LLC201221
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—
+4K111469Staxxsd SystemSpine Wave, Inc.20110—
+4K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+4K102067Endoskeleton toTitan Spine, LLC2010337—
+4K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+4K090315Staxx XD SystemSpine Wave, Inc.20096—
+4K091381Ibex Spinal SystemEbi, L.P.2009181—
+4K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+4K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070—
+4K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+4K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+4K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+4K061752Spinal Usa VBR SystemSpinal USA20060—
+4K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+4K052170Seaspine VBR SystemSeaspine, Inc.200513—
+4K052384Lanx VBR SystemLanx, LLC2005455—
+4K043479MC+ Partial VBRLdr Spine USA20051,214—
+4K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+4K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology20051,571—
+4K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+4K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K242303MOD-COrthomod, LLC20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—