510(k) Report

Devices descending from K152604

159 later devices reach KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K242042TriALTIS™ Spine SystemMedos International SARL20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K223294SpineJack® Expansion KitStryker Instruments20221—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K250637VCFix Spinal SystemAmber Implants20250—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—