510(k) Report

Devices descending from K030744

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+8K172480icotec Interbody Cage SystemIcotec AG20185—
+8K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K173537Concorde Lift™Medos International SARL20181—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+8K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+8K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+8K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+8K171704CAPRI Corpectomy Cage SystemK2m201710—
+8K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+8K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+8K162206Zavation IBFZavation, LLC201724—
+8K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+8K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+8K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+8K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+8K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+8K153436LATERAL Spine Truss System4Web, Inc.20165—
+8K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+8K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+8K151756Sterispine LC CageSafe Orthopaedics20150—
+8K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+8K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+8K142392Zavation Posterior LEIFZavation, LLC20150—
+8K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+8K142271Zavation Z-Link LumbarZavation, LLC20149—
+8K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+8K141005Z-Link CervicalZavation, LLC20144—
+8K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+8K133893Sterispine LC CageSafe Orthopaedics20141—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K2530413d Cage CervicalFims Co., Ltd.20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+9K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K211413BEE PLIF CageNGMedical GmbH20211—
+9K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+9K200429BEE CagesNGMedical GmbH202111—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+9K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+9K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+9K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+9K183243Velofix TLIF CageU&I Corporation20190—
+9K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+9K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+9K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+9K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+9K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—