510(k) Report

Devices descending from K003155

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K131833Centurion Poct SystemOrthofix, Inc.20142—
+9K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+9K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+9K120998Solstice Cross ConnectorLife Spine20121—
+10K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+10K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K242042TriALTIS™ Spine SystemMedos International SARL20241—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K233256Robotic Integration InstrumentsDePuy Synthes20240—
+10K240526POWEReam Xia/SerratoStryker Instruments20240—
+10K234150Lucent® XPSpinal Elements20240—
+10K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+10K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+10K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+10K222789VADER® Pedicle System, G21 CementIcotec AG202352
+10K223294SpineJack® Expansion KitStryker Instruments20221—
+10K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+10K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K222698CUVIS-spineCurexo, Inc.20220—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+10K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+10K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+10K210728CONDUIT InstrumentsMedos International SARL20215—
+10K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+10K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+10K193129Yukon OCT Spinal SystemK2m, Inc.202001
+10K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+10K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+10K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+10K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+10K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+10K181014Tritanium PL CageStryker Spine2018137—
+10K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+10K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+10K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+10K172194Connector SystemOrthofix, Inc.2017162
+10K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+10K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+10K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+10K161149PASS OCT Spinal SystemMedicrea International SA20160—
+10K160756PASS OCT Spinal SystemMedicrea International SA20160—
+10K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+10K153169PASS OCT Patient Specific RodsMedicrea International20164—
+10K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+10K152211PCT SystemCentinel Spine, Inc.20150—
+10K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+10K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+10K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+10K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+11K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+11K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K250637VCFix Spinal SystemAmber Implants20250—
+11K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+11K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+11K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+11K232628VADER® Pedicle SystemIcotec AG20241—
+11K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+11K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+11K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+11K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+11K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+11K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+11K190751Connector SystemOrthofix, Inc.20193—
+11K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+11K171425Concorde LiftMedos International SARL201782
+12K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+12K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+12K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+12K182349Concorde LiftMedos International SARL20190—
+12K173537Concorde Lift™Medos International SARL20181—