510(k) Report

Devices descending from K020699

636 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+1K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+1K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K103292Trio Trauma Spinal SystemStryker Corporation201185—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+2K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+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—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+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—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K173508Everest Spinal SystemK2m20189—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—