510(k) Report

Devices descending from K052123

774 later devices reach Synthes Pangea System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+5K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172194Connector SystemOrthofix, Inc.2017162
+5K171881JAZZ Passer BandImplanet, S.A.20170—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+5K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K161016Z-Clamp ISP SystemZavation, LLC20160—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K160698LigaPASSMedicrea International SA201612—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K151740JAZZ SystemImplanet, S.A.201512—
+5K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+5K143759JAZZ SystemImplanet, S.A.201513—
+5K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133617Jazz SystemImplanet, S.A.201414—
+5K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K123138Pass LP Spinal SystemMedicrea International2013132—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—