510(k) Report

Devices descending from K070387

248 later devices reach Expedium Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+1K111571Viper SystemsJohnson & Johnson2011203—
+1K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+1K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+2K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+2K182240PASS LP Spinal SystemMedicrea International SA20182—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K121728Tiger Spine SystemCorelink, LLC201250—
+2K121172Reform Pedicle Screw SystemSpinal USA201233—
+2K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+2K121020Viper SystemDepuy Spine, Inc.201294—
+2K120696Tiger Spine SystemCorelink, LLC201241—
+2K080767Conquest Spinal SystemLife Spine200821—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K253249TriALTIS™ Spine SystemMedos International SARL20251—
+3K252437JAZZ Spinal SystemImplanet20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K240392JAZZ Spinal SystemImplanet20241—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231658VEOS Spinal Fixation SystemSpineway20230—
+3K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+3K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+3K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+3K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+3K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+3K123373Nautilus Spinal SystemLife Spine201317—
+3K111953Nautilus Spinal SystemLife Spine20123—
+3K090320Conquest Spinal SystemLife Spine20092—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231479TriALTIS Spine SystemMedos International SARL20238—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—