510(k) Report

Devices descending from K031175

928 later devices reach Click'x Monoaxial Screws and Hooks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+4K143350Nile Alternative FixationK2m, Inc.201510—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142699LITe Plate SystemStryker Corporation201446—
+4K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+4K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+4K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+4K132395LigapassMedicrea International201323—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K132287Jazz SystemHogan Lovells US LLP201315—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K124014Surefix Interspinous Fusion SystemJg Spine, LLC20130—
+4K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+4K123552Instinct Java SystemZimmer Spine201301
+4K130176Firebird Spinal Fixation SystemOrthofix20135—
+4K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+4K123717UcentumUlrich GmbH & Co. KG2013171
+4K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+4K121541Jazz SystemImplanet, S.A.201227—
+4K120564Calypso SystemHogan Lovells US LLP201216—
+4K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+4K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+4K112493Pass LP Spinal SystemMedicrea International20111—
+4K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K110497Pass LP Spinal SystemMedicrea International20111331
+4K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+4K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+4K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+4K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+4K092610Modification to Beacon Stabilization SystemGlobus Medical, Inc.2009375—
+4K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+4K080767Conquest Spinal SystemLife Spine200821—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240963Spinal SystemTeslake, Inc.20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—