Zimmer® Persona® Personalized Knee System— 510(k) K251840
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K251840 for Zimmer® Persona® Personalized Knee System, Substantially Equivalent on 2026-05-28. Applicant: Zimmer, Inc.. Device class: 2.
Summary
Zimmer's Persona Personalized Knee System is filed under MBH, which the record names "Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer".
Class II, 21 CFR 888.3565. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).
Zimmer filed from Warsaw, Indiana. Review took 346 calendar days (June 16, 2025 to May 28, 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.