510(k) Report

Devices descending from K072991

647 later devices reach Patriot Spacers: Colonial Acdf through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250540SABER-C SystemElevation Spine20252—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+3K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+3K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+3K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—