510(k) Report

Devices descending from K070551

193 later devices reach Modification to: Pioneer Surgical Technology Quantum Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+1K091266Theken Coral Spinal SystemTheken Spine, LLC200915—
+1K080504Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology200892—
+1K080026Quantum-Mis Cannulated SystemPioneer Surgical Technology200812—
+1K070973Quantum Spinal SystemPioneer Surgical Technology2007178—
+2K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+2K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+2K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+2K120047Coral Spinal SystemTheken Spine, LLC201214—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology201090—
+2K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology20108—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2008174—
+2K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology2007177—
+3K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+3K100297Pass LP Spinal SystemMedicrea Technologies2010136—
+3K081296Preference Pedicle Screw SystemUs Spine20083—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K123552Instinct Java SystemZimmer Spine201301
+4K112493Pass LP Spinal SystemMedicrea International20111—
+4K110497Pass LP Spinal SystemMedicrea International20111331
+4K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+4K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+5K123138Pass LP Spinal SystemMedicrea International2013132—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+6K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+6K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+6K142798PASS LP Spinal SystemMedicrea International SA201584—
+6K150049PASS LP Spinal SystemMedicrea International20150—
+6K141398Pass LP Spinal SystemMedicrea International SA2015101
+6K140738Pass LP Spinal SystemMedicrea International201447—
+6K132574Pass LP Spinal SystemMedicrea International20130—
+6K132575Pass LP Spinal SystemMedicrea International20130—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+7K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+7K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+7K202771CD Horizon Spinal SystemMedtronic202021—
+7K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+7K160640PASS XS Spinal SystemMedicrea International SA20160—
+7K161627PASS LP Spinal SystemMedicrea International SA20167—
+7K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—