510(k) Report

Devices descending from K051856

45 later devices reach TRANS1 Facet Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073515TRANS1 Facet ScrewTrans1 Incorporated200844—
+2K152137FacetBRIDGE SystemLdr Spine USA20161—
+2K142980Proficient (TM) Facet Screw Spine SystemSpine Wave, Inc.20150—
+2K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC201311—
+2K130863Facet Screw SystemSpinal USA20131—
+2K120597KompredaCustom Spine, Inc.20130—
+2K113011Spartan S3 Facet SystemAmendia, Inc.20110—
+2K112097Gibralt Spine Systems Facet Screw 04.0,04.5Exactech, Inc.20110—
+2K101284Facet Screw SystemNuvasive, Inc.20102—
+2K092568Spartan S3 Facet SystemAmendia, Inc.200929—
+2K092464Spineology Facet ScrewSpineology, Inc.20096—
+2K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc.20088—
+3K253432DiversiVy™ Facet Screw SystemVy Spine, LLC20260—
+3K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+3K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc.201718—
+3K161798FacetBRIDGE® SystemLdr Spine USA, Inc.20160—
+3K123497Facet Screw SystemFacet-Link, Inc.20131—
+3K120340Venus Facet Screw SystemApollo Spine, Inc.201226—
+3K110170Raptor Facet Fixation SystemAlphatec Spine, Inc.20110—
+3K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.20101—
+3K102438Primalok Facet Fixation SystemOsteomed LP201041
+3K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc.20093—
+4K251714Ion-CSurGenTec, LLC20260—
+4K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+4K243265Ion 3DSurGenTec, LLC20241—
+4K232468SC Medica FFXSc Medica20243—
+4K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+4K240086Ion 3DSurGenTec, LLC20243—
+4K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc.20239—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc.20230—
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K183589PMT Facet ScrewProvidence Medical Technology, Inc.20198—
+4K150223Facet-Link Stabilization PlatformFacet-Link, Inc.20150—
+5K261209Ion-LSurGenTec, LLC20260—
+5K253190CORUS-LX ImplantProvidence Medical Technology, Inc.20250—
+5K252153FFX Facet Fixation SystemSc Medica20252—
+5K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.20251—
+5K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+5K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+5K241416Ion 3DSurGenTec, LLC20242—
+5K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc.20227—
+6K250679FFX Facet Fixation SystemSc Medica20250—
+6K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc.20244—
+7K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.20260—