510(k) Report

Devices descending from K081849

753 later devices reach Blackstone Pillar SA Partial Vertebral Body Replacement Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232315Catalyst Bone Void FillerOssdsign AB20237—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+4K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K200919Idys ALIF 3DTiClariance20210—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+4K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K192993Scarlet AL-TSpineart20201—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—