510(k) Report

Devices descending from K052069

549 later devices reach Protex Stabilization System with Additional Componentes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K131533Cayman MI Plate SystemK2m, Inc.201372—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K121568Dali Spinal Fixation SystemAccel Spine20121—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+5K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+5K182182YUKON OCT Spinal SystemK2m20185—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—