510(k) Report

Devices descending from K050979

67 later devices reach S4 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+1K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+1K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+1K133214Blackbird Spinal SystemChoicespine, LP20143—
+1K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+1K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+1K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+1K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+1K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+1K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+1K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+1K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+2K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+2K220025ARx® Spinal SystemLife Spine, Inc.20220—
+2K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+2K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+2K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+2K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+2K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+2K152211PCT SystemCentinel Spine, Inc.20150—
+2K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+2K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+2K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+2K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+2K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+3K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+3K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+3K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+3K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+4K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+5K203205Navigated Spine InstrumentsStryker Spine20218—
+5K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+7K260546Q Pedicle InstrumentsK2m, Inc.20260—
+7K252873Q Interbody InstrumentsK2m, Inc.20260—
+7K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+7K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+8K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+8K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+8K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—