Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)— 510(k) K242543
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K242543 for Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs), Substantially Equivalent on 2024-11-22. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- 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
Recent devices under product code MBH
view all- K253728 — EVOLUTION® AM BIOFOAM® Tibial System
- K251840 — Zimmer® Persona® Personalized Knee System
- K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
- K253328 — GMK 3D Metal Tibial Tray Extension
- K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
More clearances from Zimmer, Inc.
view all- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K253566 — Affixus Retrograde Femoral Nailing System
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.