510(k) Report

Devices descending from K001864

733 later devices reach Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+5K200896Solstice CCILife Spine, Inc.20200—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K173508Everest Spinal SystemK2m20189—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+5K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+5K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+5K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+5K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+5K142741OASYS SystemStryker Corporation201537—
+5K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+5K120899Range Spinal System, Unit RodK2m, Inc.201235—
+5K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+5K110551Expedium Spine SystemJohnson & Johnson20111—
+5K111571Viper SystemsJohnson & Johnson2011203—
+5K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+5K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+5K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+5K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+5K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+5K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—