510(k) Report

Devices descending from K990745

916 later devices reach Modification to Synthes Universal Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+7K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+7K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+7K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+7K191217Jazz PFImplanet, S.A.20190—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+7K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+7K172941CASCADIA Interbody SystemK2m201852—
+7K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+7K172021LigaPASSMedicrea International SA201711—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+7K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+7K160362Z-Span Plate SystemZavation, LLC20163—
+7K142798PASS LP Spinal SystemMedicrea International SA201584—
+7K150049PASS LP Spinal SystemMedicrea International20150—
+7K141398Pass LP Spinal SystemMedicrea International SA2015101
+7K140738Pass LP Spinal SystemMedicrea International201447—
+7K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+7K132574Pass LP Spinal SystemMedicrea International20130—
+7K132575Pass LP Spinal SystemMedicrea International20130—
+7K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+8K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+8K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+8K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+8K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+8K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+8K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—