510(k) Report

Devices descending from K041801

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152174Sniper Spine SystemSpine Wave, Inc.20158—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+4K143350Nile Alternative FixationK2m, Inc.201510—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+4K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+5K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+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—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+5K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—