510(k) Report

Devices descending from K052151

562 later devices reach Synthes Pangea Monoaxial System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K170647Connector SystemOrthofix, Inc.201718—
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+4K123552Instinct Java SystemZimmer Spine201301
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+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—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+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—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—