Clearance Summary
iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System received FDA 510(k) clearance under submission number K243768, sponsored by Restor3D, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-03-27.
- Submission: K243768
- Applicant / Sponsor: Restor3D, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3565
- Decision date: 2025-03-27
Classification & Regulation
This clearance is catalogued under FDA product code MBH and 21 CFR 888.3565, within the Orthopedic review panel as a Class II device.