EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161945 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 device is a revision knee femoral augment and stem extension system designed for use in total knee arthroplasty revision procedures. It consists of a femoral augment component with a 5mm thickness and a stem extension component measuring 40mm in length, intended to address bone loss and provide stability in complex revision cases.
The device is supplied as a sterile, single-use implant system manufactured by Encore Medical L.P. It received FDA 510(k) clearance under K161945 with product code JWH and is classified under the Orthopedic advisory committee. The device is intended for use in hospital surgical settings by qualified orthopedic surgeons.
Frequently asked questions
What is the EXPRT Revision Knee system used for?
The EXPRT Revision Knee system is used in total knee arthroplasty revision procedures to address bone loss and provide stability in complex cases.
Is the EXPRT Revision Knee system supplied sterile?
Yes, the EXPRT Revision Knee system is supplied as a sterile, single-use implant system.
What are the dimensions of the femoral augment and stem extension components?
The femoral augment component has a 5mm thickness and the stem extension component measures 40mm in length.
Who is the intended user of the EXPRT Revision Knee system?
The EXPRT Revision Knee system is intended for use by qualified orthopedic surgeons in hospital surgical settings.
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: EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem ..., EXPRT™ Revision Knee - Enovis, Exprt Revision Knee Femoral Augment (5mm), Exprt Revision Knee Stem ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161945 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Encore Medical L.P.
Sources (1)
- FDA 510(k) K161945 24 fields · synced Sep 22, 2026