DeviceClearance

Freedom Total Knee System (E-Poly Tibial Liners)— 510(k) K261563

Substantially Equivalent

Maxx Orthopedics, Inc.

FDA 510(k) clearance K261563 for Freedom Total Knee System (E-Poly Tibial Liners), Substantially Equivalent on 2026-08-07. Applicant: Maxx Orthopedics, Inc.. Device class: 2.

Summary

Maxx Orthopedics' Freedom Total Knee System (E-Poly Tibial Liners) is filed under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). The record gives no sizes.

Class II, 21 CFR 888.3560. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

Maxx filed from Norristown, Pennsylvania. Review took 88 calendar days (May 11 to August 7, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant
Maxx Orthopedics, Inc.
Product code
Product code JWH
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norristown, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JWH

product code JWH
Death
26
Injury
51,564
Malfunction
9,725
Other
9
Total
61,324

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.