Summary
Barricaid’s implant received original FDA PMA P160050 on February 8, 2019. It is intended for a defined group of skeletally mature discectomy patients with large annular defects at one level between L4 and S1. The linked manufacturer IFU specifies additional patient-selection restrictions, contraindications and warnings. The instrument-tray/defect-measurement kit has a separate 510(k), K201676; that clearance is not the implant’s marketing authorization. [13][9][27]
The current-family snapshot contains one original PMA, one instrument-tray clearance and two recall events. Eleven PMA supplements document subsequent changes without increasing the original-approval count. S010 approved a 6 mm baseplate configuration in October 2025, and S012 concerns a delivery-sheath manufacturing change in March 2026. No De Novo grant was found in the named searches. The 2007 fixation-staple clearance is retained outside current totals because current commercial linkage is unconfirmed. [22][24][26][25]
FDA recall Z-2688-2024 remains open and classified as Class II. It concerns the Barricaid Impactor (REF BAR-IMPACTOR; P/N 400906-A), lots 10282203, 06152307, 08292301 and 10112307, after units were found missing a weld. It is a specified-lot instrument recall. FDA’s record provides the affected scope and actions. The separate 2020 implant-labeling recall, Z-2798-2020, was terminated. [30][28]
FDA’s safety review and the manufacturer IFU discuss implant-specific risks, including migration, removal/reoperation and vertebral endplate changes. The FDA post-approval database lists extended follow-up of the premarket cohort as ongoing, with endplate lesions among the monitored issues. Marketing claims and study results should be interpreted within their patient population, follow-up period and labeling scope. [11][9][12]
