510(k) Report

Devices descending from K142095

254 later devices reach Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K183092Kuros TLIF CageKuros Biosciences B.V20190—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261408SABER-XA SystemElevation Spine20260—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—