510(k) Report

Devices descending from K031585

579 later devices reach U&I, Optima, Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+1K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+1K141850Flospine Pedicle Screw SystemFlospine20140—
+1K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+1K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+1K130073Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal RodsMikron Makina Sanayi VE Ticaret Ltd. Sti.20135—
+1K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+1K1216154CIS Vane Spine SystemSolco Biomedical Co., Ltd.20121—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K113361Securis Spinal FixationCumtom Spine20120—
+1K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+1K111995Xingtm Spine SystemImplanova Co., Ltd.20110—
+1K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+1K1024584CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd.20114—
+1K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+1K1018184CIS Vane Spine SystemSolco Biomedical Co., Ltd.20112—
+1K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123—
+1K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+1K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+1K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+1K100706Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2010124—
+1K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+1K092011Norm Spinal SystemNorm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar20090—
+1K081145Modification to 4CIS Vane Spine SystemSolco Biomedical Co., Ltd.2008127—
+1K081108Monopoly Pedicle Screw SystemSignus Medical, LLC20080—
+1K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+1K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+1K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+1K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+1K072436Mega Spine SystemBk Meditech, Co., Ltd.20079—
+1K071879Zimmer Dto ImplantZimmer Spine, Inc.200711
+1K071438PSS SystemSpinal USA200739—
+1K0637084S Spinal SystemTaeyeon Medical Co., Ltd.20078—
+1K062785LTD Polyaxial Fixation SystemUs Spine200641—
+1K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+1K0607024CIS Vane Spine SystemSolco Biomedical Co., Ltd.2006166—
+1K053573GSS Pedicle Screw SystemGS Medical Co., Ltd.2006181—
+1K053070Contour II Spinal SystemAltiva Corp.20060—
+1K0504714CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd.2005127—
+1K043578The 4CIS Spinal System and 4CIS Low Back SystemSolco Biomedical Co., Ltd.2005125—
+1K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.20041801
+2K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+2K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, 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—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+2K212700Dyflex-IITaeyeon Medical Co., Ltd.20220—
+2K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K2024984CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited20213—
+2K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+2K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K182721Choice Spine Navigation SystemChoicespine, LP20192—
+2K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+2K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+2K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+2K180324Patriot Spinal Fixation SystemValorus Spine20180—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K172546AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.201712—
+2K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+2K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+2K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+2K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+2K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K151977icotec Pedicle SystemIcotec AG201630—
+2K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+2K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+2K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+2K131343Reform Pedicle Screw SystemSpinal USA201331—
+2K130279Reform Pedicle Screw SystemSpinal USA201331—
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+2K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+2K122931S-Lok PSS SystemSpinal USA20120—
+2K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—