510(k) Report

Devices descending from K994121

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+4K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K171321K2M Navigation InstrumentsK2m201711
+4K172021LigaPASSMedicrea International SA201711—
+4K172194Connector SystemOrthofix, Inc.2017162
+4K171881JAZZ Passer BandImplanet, S.A.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161016Z-Clamp ISP SystemZavation, LLC20160—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+4K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+4K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+4K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+4K123138Pass LP Spinal SystemMedicrea International2013132—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120571Synthes Uss ConnectorSynthes Spine201274—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—