Freedom Total Knee Cruciate Retaining (CR) Femoral Component
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091280 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 Total Knee Cruciate Retaining (CR) Femoral Component is a femoral component of a total knee system intended to replace the femoral articular surface in knee arthroplasty. It is designed to retain the posterior cruciate ligament during knee replacement surgery.
This component is supplied non-sterile and is intended for single use. It is used in orthopedic surgical settings and is authorized under FDA 510(k) clearance K091280 with product code JWH. The device is not MRI conditional unless explicitly stated, and no sterility, size, or storage details are provided in the data.
Frequently asked questions
What is the Freedom Total Knee CR Femoral Component used for?
It is a femoral component of a total knee system intended to replace the femoral articular surface in knee arthroplasty and is designed to retain the posterior cruciate ligament during knee replacement surgery.
How is the Freedom Total Knee CR Femoral Component supplied and is it reusable?
The component is supplied non-sterile and is intended for single use only, meaning it should not be reprocessed or reused after surgical implantation.
What regulatory authorization does the Freedom Total Knee CR Femoral Component have?
It is authorized under FDA 510(k) clearance K091280 with product code JWH, and was found substantially equivalent to a predicate device.
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™ Knee Solutions | Maxx Orthopedics, Freedom Total Knee Cruciate Retaining (Cr) Femoral Component, Freedom® Total Knee System Surgical Technique Guide | Maxx Orthopedics, PDF Freedom Total Knee System - maxxortho.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091280 | Class II | Active |
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Manufacturer
- Manufacturer
- Maxx Orthopedics, Inc.
Sources (1)
- FDA 510(k) K091280 24 fields · synced Oct 6, 2026