510(k) Report

Devices descending from K031635

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K192993Scarlet AL-TSpineart20201—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+5K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K183064TxTi IBF SystemInnovasis, Inc.2019481
+5K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+5K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181818Scarlet AL-TSpineart201864—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+5K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+5K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+5K181246Zavation IBF SystemZavation Medical Products, LLC201822—