Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)— 510(k) K253189
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K253189 for Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs), Substantially Equivalent on 2026-03-09. Applicant: Zimmer, Inc.. Device class: 2.
Summary
Zimmer's Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) is filed under MBH, semi-constrained, uncemented, porous-coated polymer/metal/polymer patello/femorotibial knee prostheses. The record doesn't list femur sizes.
Class II, 21 CFR 888.3565. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Zimmer filed from Warsaw, Indiana. The decision came 164 calendar days after receipt (September 26, 2025 to March 9, 2026).
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Product code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
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Adverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.