510(k) Report

Devices descending from K904243

580 later devices reach TSRH Variable Angle Sacral Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997579—
+2K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+2K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+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—
+2K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+2K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+2K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+2K100956Spondy Spinal Fixation SystemAllure Spine LLC201017—
+2K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemBiomet Spine (Aka Ebi, LLC)2010144—
+2K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P.2010104—
+2K100377Diamondback Spinal SystemEminent Spine201029—
+2K092420KRD1 Pedicle Screw SystemSpinefrontier, Inc.200962
+2K090523Polaris Spinal SystemEbi, L.P.2009156—
+2K071377Polaris BE RodsBiomet Spine20070—
+2K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999250—
+2K983353SCS Spinal SystemOrthotec, Inc.19982—
+2K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998251—
+2K980484Aesculap Spine System EvolutionAesculap, Inc.1998251—
+2K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Cross Medical Products, Inc.1998311—
+2K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998529—
+3K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+3K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+3K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K123717UcentumUlrich GmbH & Co. KG2013171
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+3K112684Mont Blanc Pedicle Screw SystemsQualgenix20125—
+3K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+3K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K110633Lancer Pedicle Screw SystemSpinal Solutions, LLC201108
+3K111301Instinct Java SystemZimmer Spine201131
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K103393Polaris Spinal SystemBiomet Spine2011104—
+3K100220Polaris Spinal SystemEbi, L.P.2010153—
+3K080241DDS Stabilization SystemParadigm Spine, LLC20085—
+3K081108Monopoly Pedicle Screw SystemSignus Medical, LLC20080—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+3K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+3K072685Ngarde SystemN Spine, Inc.200709
+3K062912Scient'x Spinal SystemScient'X200736—
+3K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+3K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+3K051063Polyaxial Hemispherical Spinal ScrewsScient'X200537—
+3K040747Aladyn Rigid Spine PlateScient'X20040—
+3K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+3K020245Modification to Isobar Spinal SystemScien'Tx USA, Inc.200243—
+3K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—