DeviceClearance

Product code MBH— Orthopedic

Zimmer Persona Personalized Knee System

Classification name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class
Class 2
Regulation
21 CFR 888.3565
Advisory panel
Orthopedic
Total cleared
144
First cleared
Most recent

Market context for product code MBH

FDA has cleared 144 devices under product code MBH between 2003 and 2026, filed by 47 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MBH

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 →

Recent clearances under product code MBH

1–100 of 144

Data sourced from openFDA. This site is unofficial and independent of the FDA.