510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+4K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K153621Juliet® TiSpineart2016751
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153400ProLift Expandable SystemLife Spine, Inc.201672—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K141135Juliet LLSpineart2014146—
+4K1421124WEB Spinal Implant Products4Web, Inc.201433—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+4K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014267—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K132596Proposed OptimusCustom Spine, Inc.201451
+4K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+4K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+4K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+4K111726Pathway AvidCustom Spine, Inc.201295—
+4K112359Prow FusionNlt Spine, Ltd.2011601—
+4K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+4K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+4K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+4K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+4K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+4K061752Spinal Usa VBR SystemSpinal USA20060—
+4K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+4K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+4K051454Aleutian Spacer SystemK2m, LLC2005666—
+4K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+4K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005894—
+5K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+5K261049Scala® TLSpineart SA20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223654Medussa-PL CageMedyssey USA, Inc.20220—
+5K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—