510(k) Report

Devices descending from K052385

253 later devices reach Tangors Polyaxial System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123717UcentumUlrich GmbH & Co. KG2013171
+1K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+1K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+2K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+2K111571Viper SystemsJohnson & Johnson2011203—
+2K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K121728Tiger Spine SystemCorelink, LLC201250—
+3K121172Reform Pedicle Screw SystemSpinal USA201233—
+3K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K120696Tiger Spine SystemCorelink, LLC201241—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K231658VEOS Spinal Fixation SystemSpineway20230—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—