510(k) Report

Devices descending from K951116

416 later devices reach Acromed Pedicle Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+5K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K173508Everest Spinal SystemK2m20189—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+5K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+5K100605Mis SystemSpine Wave, Inc.201033—
+5K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+5K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—