Freedom Total Knee System (E-Poly Tibial Liners)— 510(k) K261563
Substantially EquivalentMaxx 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.
Clearance details
- Applicant
- Maxx Orthopedics, Inc.
- Product code
- 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
Recent devices under product code JWH
view allMore clearances from Maxx Orthopedics, Inc.
view allAdverse 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.