510(k) Report

Devices descending from K012773

158 later devices reach Discovery Facet Screw Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+1K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+1K173198Facet Screw Fixation SystemU&I Corporation20180—
+1K131417Facet FixxNexxt Spine, LLC2013130—
+1K123497Facet Screw SystemFacet-Link, Inc.20131—
+1K121850Typhoon (TM) Facet Screw Fixation SystemChoicespine, LP20120—
+1K113011Spartan S3 Facet SystemAmendia, Inc.20110—
+1K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.20101—
+1K102438Primalok Facet Fixation SystemOsteomed LP201041
+1K101284Facet Screw SystemNuvasive, Inc.20102—
+1K100154Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc.201035—
+1K092568Spartan S3 Facet SystemAmendia, Inc.200929—
+1K071420Chameleon Fixation SystemSpinefrontier, Inc.20081531
+1K061041US Spine Facet Fixation SystemUs Spine20063—
+2K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+2K180729FaSet Fixation SystemHuvexel Co., Ltd.20183—
+2K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc.201718—
+2K150223Facet-Link Stabilization PlatformFacet-Link, Inc.20150—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K123932Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc.201318—
+2K123218Illico FS Facet Fixation SystemAlphatec Spine, Inc.20120—
+2K120340Venus Facet Screw SystemApollo Spine, Inc.201226—
+2K110170Raptor Facet Fixation SystemAlphatec Spine, Inc.20110—
+2K112097Gibralt Spine Systems Facet Screw 04.0,04.5Exactech, Inc.20110—
+2K092464Spineology Facet ScrewSpineology, Inc.20096—
+3K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+3K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+3K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc.20239—
+3K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc.20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K222515FaSet Fixation SystemDio Medical Corporation20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+3K183589PMT Facet ScrewProvidence Medical Technology, Inc.20198—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K152137FacetBRIDGE SystemLdr Spine USA20161—
+3K142980Proficient (TM) Facet Screw Spine SystemSpine Wave, Inc.20150—
+3K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC201311—
+4K261209Ion-LSurGenTec, LLC20260—
+4K251714Ion-CSurGenTec, LLC20260—
+4K253190CORUS-LX ImplantProvidence Medical Technology, Inc.20250—
+4K252153FFX Facet Fixation SystemSc Medica20252—
+4K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.20251—
+4K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+4K243265Ion 3DSurGenTec, LLC20241—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K232468SC Medica FFXSc Medica20243—
+4K240086Ion 3DSurGenTec, LLC20243—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc.20227—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K161798FacetBRIDGE® SystemLdr Spine USA, Inc.20160—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K250679FFX Facet Fixation SystemSc Medica20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc.20244—
+5K241416Ion 3DSurGenTec, LLC20242—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—