Clearance Summary
Pectus Blu System received FDA 510(k) clearance under submission number K261002, sponsored by Biomet Microfixation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-06-02.
- Submission: K261002
- Applicant / Sponsor: Biomet Microfixation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2026-06-02
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.