510(k) Report

Devices descending from K081177

848 later devices reach Blackstone Medical, Inc., Pillar Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+1K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+1K111569Plateau Spacer SystemLife Spine2011181—
+1K103111Forza Spacer SystemOrthofix, Inc.20113431
+1K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+2K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+2K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+2K213417Ghost Spacer SystemLife Spine, Inc.20220—
+2K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+2K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+2K193521Steerable Plateau TiLife Spine, Inc.20201—
+2K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+2K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+2K182470Plateau Spacer SystemLife Spine20180—
+2K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+2K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+2K161129Pillar SA PTCOrthofix, Inc.201619—
+2K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+2K140303Alamo TAlliance Partners, LLC20140—
+2K132596Proposed OptimusCustom Spine, Inc.201451
+2K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+2K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K131077Life Spine Plateau Spacer SystemLife Spine201310—
+2K122444Cervical CageEisertech, LLC201222—
+2K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+2K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+2K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+3K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+3K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+3K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—