MOTOTM Partial Knee & MOTO PFJ Systems Extension— 510(k) K213071

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K213071 for MOTOTM Partial Knee & MOTO PFJ Systems Extension, Substantially Equivalent on 2021-11-16. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 2021-09-23
Decision date: 2021-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.