510(k) Report

Devices descending from P000028

1,287 later devices reach Affinity (TM) Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+7K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K171425Concorde LiftMedos International SARL201782
+7K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+7K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K182349Concorde LiftMedos International SARL20190—
+8K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+8K173537Concorde Lift™Medos International SARL20181—
+8K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+8K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+8K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+9K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—