510(k) Report

Devices descending from K100952

314 later devices reach Modification to Synthes Matrix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231515MySpine Cervical GuidesMedacta International S.A.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+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—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—