510(k) Report

Devices descending from K070754

506 later devices reach Trabecular Metal Vertebral Body Replacement (VBR), Model# 06-115, 06-155 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K183092Kuros TLIF CageKuros Biosciences B.V20190—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+9K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K212358Romero Cervical CageSpineup, Inc.20226—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K230026SqualeImplanet, S.A.20230—