510(k) Report

Devices descending from K994121

942 later devices reach Small Stature Uss through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+3K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173508Everest Spinal SystemK2m20189—
+3K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K170647Connector SystemOrthofix, Inc.201718—
+3K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+3K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162764Jazz Frame SystemImplanet, S.A.20176—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K160698LigaPASSMedicrea International SA201612—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151740JAZZ SystemImplanet, S.A.201512—
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+3K143759JAZZ SystemImplanet, S.A.201513—
+3K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—