510(k) Report

Devices descending from K013665

248 later devices reach Pyramid Anterior Plate Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated20151—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—