510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K190376PASS LP Spinal SystemMedicrea International SA201915
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K180324Patriot Spinal Fixation SystemValorus Spine20180—
+1K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+1K153404Zavation Spinal SystemZavation, LLC20161—
+1K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+1K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+1K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+1K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K122229Viceroy Spinal SystemTorrey Spine20120—
+1K120091R&D Innovation Pedicle Screw SystemR&D Innovation, LLC20121—
+1K113361Securis Spinal FixationCumtom Spine20120—
+1K120696Tiger Spine SystemCorelink, LLC201241—
+1K112484Zavation Spinal SystemZavation, LLC20115—
+1K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+1K103490Expedium Spine System, Moss Miami Spine SystemJohnson & Johnson201120—
+1K100757Tilock Pedicle Screw SystemGenesys Spine201091
+1K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+1K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+1K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+1K071743Pillar Pedicle Screw SystemThe 4th Column, LLC20070—
+1K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+1K062196SFX Snap-Fit Cross ConnectorDepuy Spine, Inc.2006559—
+1K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+1K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005495—
+1K041592Coral Spinal SystemTheken Surgical20042611
+1K010576Monarch Spine SystemDepuyacromed2001596—
+1K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed1999547—
+1K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998251—
+1K980484Aesculap Spine System EvolutionAesculap, Inc.1998251—
+1K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998413—
+1K964024Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc.1997700—
+2K252322SIros-X SystemGenesys Spine20250—
+2K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+2K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+2K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+2K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K172469TiLock Modular Spinal SystemGenesys Spine20170—
+2K171838TiLock2 Spinal SystemGenesys Spine20174—
+2K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+2K161627PASS LP Spinal SystemMedicrea International SA20167—
+2K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+2K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+2K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+2K120469Erisma-LPClariance20126—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+2K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+2K120047Coral Spinal SystemTheken Spine, LLC201214—
+2K113173Nanovis Spinal SystemNanovis, LLC20122—
+2K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+2K112493Pass LP Spinal SystemMedicrea International20111—
+2K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+2K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K100970Stainless Steel Spinal SystemTheken Spine, LLC20101—
+2K100377Diamondback Spinal SystemEminent Spine201029—
+2K091266Theken Coral Spinal SystemTheken Spine, LLC200915—
+2K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+2K081414Modification to Coral Spinal SystemTheken Spine, LLC200821—
+2K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc.2008538—
+2K072407Bodyform Thoracic Fixation SystemTheken Spine, LLC200787—
+2K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+2K070962Coral Pedicle Screw SystemTheken Spine, LLC2007118—
+2K071495Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company2007539—
+2K070300Expedium SFX Cross Connector SystemDepuy Spine, Inc.2007311
+2K062513Apex Spine SystemSpinecraft, Inc.2006179—
+2K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—