510(k) Report

Devices descending from K963045

662 later devices reach Synthes (U.S.a.) Universal Sacral System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+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—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K161016Z-Clamp ISP SystemZavation, LLC20160—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+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—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133617Jazz SystemImplanet, S.A.201414—
+5K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+5K123138Pass LP Spinal SystemMedicrea International2013132—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+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—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—