Identifiers
- 510(k) Number
- K131481 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Freedom PCK Components are classified as a Revision Total Knee Prosthesis (FDA Product Code JWH), designed for use in revision total knee arthroplasty. This system includes trapezoidal femoral components engineered to provide a progressive variable constraint profile, transitioning from high constraint in extension to reduced constraint in flexion. The design supports improved stability and range of motion for patients undergoing revision procedures. These components are intended for use in conjunction with stemmed tibial components as part of a total knee replacement system.
The Freedom PCK Components are supplied as a sterile, single-use orthopedic implant kit, intended for surgical use in orthopedic settings. They are FDA-cleared under a Traditional 510(k) pathway (K131481) and are not labeled for MRI compatibility. Components are packaged individually and must be stored according to manufacturer instructions to maintain sterility and integrity. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the available data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Freedom™ PCK Revision Knee System | Maxx Orthopedics, Freedom™ Knee Solutions | Maxx Orthopedics, FREEDOM PCK COMPONENTS (K131481) — FDA 510 (k) | Innolitics, Freedom® Total Knee System - Titan PCK Components (K253144) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131481 | Class II | Active |
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Manufacturer
- Manufacturer
- Maxx Orthopedics, Inc.
Sources (1)
- FDA 510(k) K131481 24 fields · synced Sep 20, 2026