510(k) Report

Devices descending from K120340

26 later devices reach Venus Facet Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183589PMT Facet ScrewProvidence Medical Technology, Inc.20198—
+1K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc.201718—
+1K152137FacetBRIDGE SystemLdr Spine USA20161—
+1K142980Proficient (TM) Facet Screw Spine SystemSpine Wave, Inc.20150—
+2K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc.20239—
+2K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc.20230—
+2K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc.20227—
+2K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+2K161798FacetBRIDGE® SystemLdr Spine USA, Inc.20160—
+3K261209Ion-LSurGenTec, LLC20260—
+3K251714Ion-CSurGenTec, LLC20260—
+3K253190CORUS-LX ImplantProvidence Medical Technology, Inc.20250—
+3K252153FFX Facet Fixation SystemSc Medica20252—
+3K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.20251—
+3K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+3K243265Ion 3DSurGenTec, LLC20241—
+3K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc.20244—
+3K232468SC Medica FFXSc Medica20243—
+3K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+3K240086Ion 3DSurGenTec, LLC20243—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.20260—
+4K250679FFX Facet Fixation SystemSc Medica20250—
+4K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+4K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+4K241416Ion 3DSurGenTec, LLC20242—