510(k) Report

Devices descending from K944736

598 later devices reach VSP (Variable Screw Placement) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K981274Acromed Timx Plate Based Low Back SystemAcromed Corp.1998597—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K010576Monarch Spine SystemDepuyacromed2001596—
+3K173508Everest Spinal SystemK2m20189—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+3K062513Apex Spine SystemSpinecraft, Inc.2006179—
+3K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+3K032604Gii Spinal Fixation SystemCo-Ligne AG20045—
+3K024348Monarch Spine SystemDepuyacromed2003578—
+3K023438Modification to Monarch Spine SystemDepuyacromed20024—
+3K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed2002496—
+3K013441Isola Polyaxial WasherDepuyacromed2001262—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210306GII Spinal Fixation SystemColigne AG20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K121568Dali Spinal Fixation SystemAccel Spine20121—
+4K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+4K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+4K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+4K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+4K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+4K100757Tilock Pedicle Screw SystemGenesys Spine201091
+4K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+4K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+4K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG20091—
+4K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+4K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+4K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+4K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+4K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+4K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+4K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+4K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+4K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+4K051089Gii Spinal Fixation SystemCo-Ligne AG20054—
+4K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005495—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243249TriALTIS™ Spine SystemMedos International SARL20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—