510(k) K251834

Persona Partial Knee by Zimmer Biomet — Product Code HSX

K251834 is an FDA 510(k) premarket notification submitted by Zimmer Biomet for the device "Persona Partial Knee". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Zimmer Biomet has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2025
Date Received
June 16, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type