510(k) Report

Devices descending from K030249

616 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K230583Tryptik TiSpineart SA20231—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+8K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230026SqualeImplanet, S.A.20230—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K203003Pantheon IBFDPantheon Spinal20210—
+9K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+9K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+9K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—