510(k) K240299

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) by Zimmer, Inc. — Product Code MBH

K240299 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)". The FDA issued a decision of Substantially Equivalent on April 26, 2024. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Zimmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2024
Date Received
February 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type