510(k) Report

Devices descending from K010911

44 later devices reach Macropore OS Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090415Eminent Spine Buttress (Fang) Plate SystemEminent Spine200951
+1K081770Black Widow Anterior Buttress PlateOmni Surgical, L.P.2009202
+1K071810Inion Spinal Graft Containment SystemInion, Ltd.20081—
+1K062181C-Jaws Cervical Compressive Mini FrameMedicrea Technologies20073—
+1K051821Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd.20052—
+1K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc.20044—
+1K014200OptimeshSpineology, Inc.20035—
+1K021039Bowti Anterior Buttress Staple SystemDepuyacromed200232—
+2K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K180755Vail ALIF Buttress Plate SystemEvolution Spine, LLC20181—
+2K180537Zavation Buttress Plate SystemZavation Medical Products, LLC20180—
+2K151360Inion Spinal Graft Containment SystemInion OY20150—
+2K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated20151—
+2K133911Genesys Spine Anterior Buttress Plate SystemGenesys Spine201416—
+2K063461Anova Containment DeviceAnova Corporation20090—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K073500Active Anterior Cervical Plate SystemSanacor20080—
+2K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC20081—
+2K072040C-Jaws Cervical Compressive Mini FrameMedicrea Technologies20070—
+2K061385Osstaple, Ossplate, OssforceBiomedical Enterprises, Inc.20071—
+2K033953Optimesh 500E Cement RestrictorSpineology, Inc.20040—
+2K040130Anterior Lumbar Buttress SystemSeaspine20044—
+3K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC20260—
+3K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+3K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC20210—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—