510(k) Report

Devices descending from K964024

700 later devices reach Depuy Motech 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—
+1K161627PASS LP Spinal SystemMedicrea International SA20167—
+1K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+1K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+1K113361Securis Spinal FixationCumtom Spine20120—
+1K112493Pass LP Spinal SystemMedicrea International20111—
+1K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+1K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+1K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+1K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+1K062136Pass 2 Spinal SystemMedicrea2006146—
+1K051044Arctec Semirigid Plating SystemAltiva Corp.20050—
+1K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed1999547—
+1K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998413—
+2K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+2K243249TriALTIS™ Spine SystemMedos International SARL20250—
+2K203023Pisces Spinal SystemOrtho Development Corporation20210—
+2K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K153413PASS LP Spinal SystemMedicrea International SA20160—
+2K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+2K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+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—
+2K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+2K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+2K121979Pass Oct Spinal SystemMedicrea International201314—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+2K113173Nanovis Spinal SystemNanovis, LLC20122—
+2K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+2K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+2K110497Pass LP Spinal SystemMedicrea International20111331
+2K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+2K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+2K100377Diamondback Spinal SystemEminent Spine201029—
+2K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+2K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+2K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+2K071743Pillar Pedicle Screw SystemThe 4th Column, LLC20070—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K061342Malibu Spinal SystemSeaspine, Inc.2006801
+2K051942Malibu Spinal SystemSeaspine, Inc.20058111
+2K051663Malibu Spinal SystemSeaspine, Inc.200581—
+2K042143Excella-M Spinal SystemInnovasis, Inc.20046—
+2K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410—
+2K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002294—
+2K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—
+3K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+3K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K150918PASS OCT Spinal SystemMedicrea International SA201513—