510(k) Report

Devices descending from K043206

1,571 later devices reach Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+6K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+6K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+6K160291Optimus ALIF SystemAmendia, Inc.20160—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+6K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+6K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+6K143616AccuLIF TL and PL CageStryker Corporation20154694
+6K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+6K141135Juliet LLSpineart2014146—
+6K141896Coroent SystemNu Vasive, Incorporated2014480—
+6K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+6K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+6K141942Midline II TICentinel Spine, Inc.2014459—
+6K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+6K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+6K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+6K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+6K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+6K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+6K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+6K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+6K130445Vault Alif SystemSpinal USA20139—
+6K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+6K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+6K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+6K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+6K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+6K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+7K263049SABER-C SystemElevation Spine20260—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+7K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+7K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242589Scarlet® AL-TSpineart SA20240—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+7K234150Lucent® XPSpinal Elements20240—