510(k) Report

Devices descending from K150231

242 later devices reach Navigated Disc Prep Instruments and CAPSTONE Trials through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—