510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+8K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+8K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+8K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+8K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+8K131449Coalition SpacerGlobus Medical, Inc.2013235—
+8K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+8K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+8K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+8K130194Acculif XL CageCoalign Innovations, Inc.20131—
+8K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+8K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+8K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+8K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+8K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+8K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+8K113346Neon SystemUlrich GmbH & Co. KG20121—
+8K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+8K112388Lanx Cervical SALanx, Inc.201126—
+8K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+8K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+8K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+9K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+9K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+9K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+9K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243249TriALTIS™ Spine SystemMedos International SARL20250—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K240160EGPS Navigated InstrumentsAstura Medical20240—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233300POWEReam 1/4 DriveStryker Instruments20231—
+9K233684TriALTIS™ Spine SystemMedos International SARL20234—
+9K231515MySpine Cervical GuidesMedacta International S.A.20230—
+9K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+9K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+9K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+9K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+9K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+9K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+9K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+9K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+9K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+9K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+9K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+9K223558CUVIS-spineCurexo, Inc.20230—
+9K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+9K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+9K230614Cortium™Ulrich Medical USA20230—
+9K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+9K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+9K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+9K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+9K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—