510(k) Report

Devices descending from K953915

765 later devices reach Moss Miami Spinal System (Anterior Use) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+4K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+4K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+4K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+4K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+4K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+4K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+4K100605Mis SystemSpine Wave, Inc.201033—
+4K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+4K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—