510(k) Report

Devices descending from K031635

1,201 later devices reach Depuy Acromed VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K192117Small VBR™Ulrich GmbH & Co. KG20196—
+7K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K182349Concorde LiftMedos International SARL20190—
+7K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+7K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+7K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+7K173537Concorde Lift™Medos International SARL20181—
+7K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+7K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+7K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K171519FLXfit™Expanding Orthopedics, Inc.2017711
+7K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+7K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+7K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+7K162262Tritanium® PL CageStryker2016132—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+7K160955Tritanium® PL CageStryker2016178—
+7K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+7K152651AccuLIF TL and PL CageStryker Corporation201530—
+7K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+7K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+7K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+7K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K172756Varian cageMedyssey USA, Inc.20171—
+8K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K141217Acculif TL and PL CageStryker Corporation20146423
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—