510(k) Report

Devices descending from K024096

466 later devices reach Optima, Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231—
+1K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+1K153404Zavation Spinal SystemZavation, LLC20161—
+1K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+1K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+1K143417ANAX 5.5 Spinal SystemU&I Corporation20154—
+1K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+1K141044M.U.S.T. ExtensionMedacta International201416—
+1K132218Perfix Iliac Screw SystemU&I Corporation20130—
+1K132101Anax 5.5 Spinal SystemU&I Corporation201313—
+1K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+1K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+1K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+1K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+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—
+1K102331LDR Spine Usa Spinetune TL Spinal SystemLdr Spine USA20106—
+1K100956Spondy Spinal Fixation SystemAllure Spine LLC201017—
+1K100373Tyche Pedicle Screw SystemKyung Won Medical Co., Ltd.20104—
+1K091725Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)U&I Corp.2009150—
+1K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+1K071879Zimmer Dto ImplantZimmer Spine, Inc.200711
+1K071857Delta Spinal Fusion SystemJemo Spine, LLC2007109—
+1K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+1K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+1K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+2K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+2K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+2K203452Nano FortiFix® SystemNanovis, LLC20200—
+2K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+2K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+2K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+2K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+2K181824CBT Screw Fixation SystemU&I Corporation20180—
+2K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+2K180324Patriot Spinal Fixation SystemValorus Spine20180—
+2K173524ANAX 5.5™ Spinal SystemU&I Corporation201721
+2K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+2K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+2K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+2K162189ANAX™ 5.5 Spinal SystemU&I Corporation20163—
+2K151977icotec Pedicle SystemIcotec AG201630—
+2K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+2K143110GALAXY MIS Screw SystemBm Korea20152—
+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—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+2K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+2K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+2K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K120760LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc.20124—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+2K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K111995Xingtm Spine SystemImplanova Co., Ltd.20110—
+2K101704Zimmer Dto Pin Press InstrumentZimmer Spine, Inc.20100—
+2K100575LDR Spine Usa Spine Tune TL Spine SystemLdr Spine USA20107—
+2K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd.20090—
+2K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K072685Ngarde SystemN Spine, Inc.200709
+2K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—