510(k) Report

Devices descending from K160125

315 later devices reach Cascadia Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—