510(k) Report

Devices descending from K990745

916 later devices reach Modification to Synthes Universal Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+5K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K150507Santis Pedicle Screw SystemLanterna Medical Technologies20150—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+5K143350Nile Alternative FixationK2m, Inc.201510—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K142699LITe Plate SystemStryker Corporation201446—
+5K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+5K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K132395LigapassMedicrea International201323—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K132287Jazz SystemHogan Lovells US LLP201315—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K124014Surefix Interspinous Fusion SystemJg Spine, LLC20130—
+5K130176Firebird Spinal Fixation SystemOrthofix20135—
+5K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+5K123717UcentumUlrich GmbH & Co. KG2013171
+5K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+5K121541Jazz SystemImplanet, S.A.201227—
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+5K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+5K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+5K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+5K103671Genesys Spine Tilock SystemGenesys Spine20118—
+5K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+5K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+5K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+5K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+5K092610Modification to Beacon Stabilization SystemGlobus Medical, Inc.2009375—
+5K080767Conquest Spinal SystemLife Spine200821—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240963Spinal SystemTeslake, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—