510(k) Report

Devices descending from K030833

1,224 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—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, 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
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+7K182349Concorde LiftMedos International SARL20190—
+7K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+7K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+7K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+7K173537Concorde Lift™Medos International SARL20181—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+7K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+7K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+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—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K192117Small VBR™Ulrich GmbH & Co. KG20196—
+8K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+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—