510(k) Report

Devices descending from K980484

251 later devices reach Aesculap Spine System Evolution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203023Pisces Spinal SystemOrtho Development Corporation20210—
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K132603Apex Spine SystemSpinecraft, LLC201325—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K130176Firebird Spinal Fixation SystemOrthofix20135—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K240963Spinal SystemTeslake, Inc.20240—
+6K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+6K150417Astra Spine SystemSpinecraft, LLC201521—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+7K211323ASTRA Spine SystemSpinecraft, LLC202112—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K190751Connector SystemOrthofix, Inc.20193—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K162786PASS LP Spinal SystemMedicrea International SA20176—
+7K161842Overwatch Spine SystemAmendia, Inc.201661
+7K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—