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
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+7K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+7K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+7K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+7K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+7K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+7K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K221244CD Horizon™ Spinal SystemMedtronic202220—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+7K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+7K201793EDEN Peek CageJmt Co., Ltd.20210—
+7K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K200919Idys ALIF 3DTiClariance20210—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+7K210359Hexanium TLIFSpinevision, S.A.S.20211—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+7K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+7K192117Small VBR™Ulrich GmbH & Co. KG20196—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+7K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+7K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K181963ostaPek Interbody Fusion CagesColigne AG20181—
+7K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+7K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+7K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—