Freedom® Total Knee System - Porous Tibial Base Plate— 510(k) K241597

Substantially Equivalent

Maxx Orthopedics, Inc.

FDA 510(k) clearance K241597 for Freedom® Total Knee System - Porous Tibial Base Plate, Substantially Equivalent on 2025-02-13. Applicant: Maxx Orthopedics, Inc..

Clearance details

Applicant: Maxx Orthopedics, Inc.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2024-06-03
Decision date: 2025-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norristown, PA, US

Download summary PDF View on FDA.gov ↗

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.