510(k) Report

Devices descending from K030744

1,040 later devices reach Blackstone Surgical Titanium Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K234150Lucent® XPSpinal Elements20240—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+8K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+8K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+8K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+8K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193521Steerable Plateau TiLife Spine, Inc.20201—
+8K193258ProLift Expandable SystemLife Spine, Inc.20203—
+8K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+8K191796Neo Cage SystemNeo Medical SA20190—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K183407Triton CageMedyssey USA, Inc.20190—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+8K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+8K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+8K182349Concorde LiftMedos International SARL20190—
+8K183092Kuros TLIF CageKuros Biosciences B.V20190—
+8K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+8K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+8K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+8K181048Neo Cage System TMNeo Medical SA20191—
+8K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+8K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K181829Velofix TLIF CageU&I Corporation20181—
+8K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+8K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+8K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+8K181337Sypher Spacer SystemBiogennix, LLC20180—
+8K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+8K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+8K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K181203Juliet TiSpineart20181—