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
+7K173128Alamo® CAlliance Partners, LLC20182—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+7K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+7K163180Hubble IIOrbbo Surgical, LLC20160—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+7K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+7K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+7K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+7K153400ProLift Expandable SystemLife Spine, Inc.201672—
+7K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+7K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+7K152651AccuLIF TL and PL CageStryker Corporation201530—
+7K152304Tritanium PL CageStryker20154481
+7K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+7K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+7K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+7K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+7K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+7K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+7K130194Acculif XL CageCoalign Innovations, Inc.20131—
+7K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+7K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241895Cannulated PsiFGuardSpineguard20240—
+8K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+8K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+8K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+8K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+8K213815SiJoin®T3Vgi Medical, Inc.20230—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+8K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+8K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+8K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+8K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K171519FLXfit™Expanding Orthopedics, Inc.2017711
+8K171425Concorde LiftMedos International SARL201782
+8K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K162262Tritanium® PL CageStryker2016132—
+8K160955Tritanium® PL CageStryker2016178—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+8K141217Acculif TL and PL CageStryker Corporation20146423