510(k) Report

Devices descending from K030744

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K172065Scarlet AC-TSpineart20172—
+7K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+7K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+7K171425Concorde LiftMedos International SARL201782
+7K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+7K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+7K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K170055CAPRI Corpectomy Cage SystemK2m201711—
+7K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+7K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+7K153621Juliet® TiSpineart2016751
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+7K141798Sypher Spacer SystemBiogennix, LLC20151—
+7K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+7K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+7K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+7K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+7K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+7K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+7K122588Vusion CS PlusOrtho Development Corp.2013206—
+7K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+7K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+7K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+7K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+7K122021Sterispine LC CageSafe Orthopaedics20122—
+7K120576Zavation Ibf SystemZavation, LLC201232—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251016MectaLIF 3D MetalMedacta International S.A.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421