Clearance Summary
JOURNEY II UK and ENGAGE Cementless Partial Knee System received FDA 510(k) clearance under submission number K222653, sponsored by Smith+Nephew, 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 2022-10-28.
- Submission: K222653
- Applicant / Sponsor: Smith+Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3535
- Decision date: 2022-10-28
Classification & Regulation
This clearance is catalogued under FDA product code NJD and 21 CFR 888.3535, within the Orthopedic review panel as a Class II device.