510(k) Report

Devices descending from K100154

35 later devices reach Fixcet Spinal Facet Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123932Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc.201318—
+1K120340Venus Facet Screw SystemApollo Spine, Inc.201226—
+1K121850Typhoon (TM) Facet Screw Fixation SystemChoicespine, LP20120—
+1K110170Raptor Facet Fixation SystemAlphatec Spine, Inc.20110—
+2K183589PMT Facet ScrewProvidence Medical Technology, Inc.20198—
+2K180729FaSet Fixation SystemHuvexel Co., Ltd.20183—
+2K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc.201718—
+2K152137FacetBRIDGE SystemLdr Spine USA20161—
+2K142980Proficient (TM) Facet Screw Spine SystemSpine Wave, Inc.20150—
+2K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC201311—
+3K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc.20239—
+3K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc.20230—
+3K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc.20227—
+3K222515FaSet Fixation SystemDio Medical Corporation20222—
+3K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+3K161798FacetBRIDGE® SystemLdr Spine USA, Inc.20160—
+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—
+4K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc.20244—
+4K232468SC Medica FFXSc Medica20243—
+4K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+4K240086Ion 3DSurGenTec, LLC20243—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.20260—
+5K250679FFX Facet Fixation SystemSc Medica20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+5K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+5K241416Ion 3DSurGenTec, LLC20242—