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
+6K172469TiLock Modular Spinal SystemGenesys Spine20170—
+6K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+6K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+6K171321K2M Navigation InstrumentsK2m201711
+6K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+6K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K161016Z-Clamp ISP SystemZavation, LLC20160—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K160698LigaPASSMedicrea International SA201612—
+6K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+6K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+6K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+6K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+6K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+6K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+6K151740JAZZ SystemImplanet, S.A.201512—
+6K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+6K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+6K143759JAZZ SystemImplanet, S.A.201513—
+6K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+6K150449LITe Plate SystemStryker Corp.201524—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K133617Jazz SystemImplanet, S.A.201414—
+6K131833Centurion Poct SystemOrthofix, Inc.20142—
+6K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+6K131533Cayman MI Plate SystemK2m, Inc.201372—
+6K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+6K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+6K123373Nautilus Spinal SystemLife Spine201317—
+6K123138Pass LP Spinal SystemMedicrea International2013132—
+6K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+6K111953Nautilus Spinal SystemLife Spine20123—
+6K090320Conquest Spinal SystemLife Spine20092—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+7K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+7K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K241258Ingenix Spinal SystemIngenium Spine20240—
+7K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+7K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—