510(k) Report

Devices descending from K121115

43 later devices reach M.U.S.T Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+1K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+1K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+1K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+1K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+1K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+1K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+1K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+1K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+1K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+1K141044M.U.S.T. ExtensionMedacta International201416—
+1K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+1K132878M.U.S.T. ExtensionMedacta International201328—
+2K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+2K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+2K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+2K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+3K231515MySpine Cervical GuidesMedacta International S.A.20230—
+3K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+3K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+3K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+4K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+4K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+4K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+5K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—