Optimotion Implants Porous Metal-Backed Patella— 510(k) K220049

Name: FDA 510(k) clearance K220049
Creator: U.S. Food and Drug Administration
Published: 2022-03-14

Substantially Equivalent

Optimotion Implants, LLC

FDA 510(k) clearance K220049 for Optimotion Implants Porous Metal-Backed Patella, Substantially Equivalent on 2022-03-14. Applicant: Optimotion Implants, LLC. Device class: 2.

Clearance details

Applicant: Optimotion Implants, LLC
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2022-01-06
Decision date: 2022-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBH

view all

K261275 — Unity Total Knee System, Unity Knee Cementless CR Femur2026-09-17
K261462 — LANDMARK Total Knee System2026-09-08
K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09

More clearances from Optimotion Implants, LLC

view all

K240938 — The Optimotion Blue Plus Knee System2024-06-27
K191084 — The Optimotion Blue Total Knee System2020-04-07

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.