# K231947: EVOLUTION® Cement Keel

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Oct 31, 2023 after 123 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K043083 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162026: EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions, Microport Orthopedics, Inc. (2017) Summary page 5.

## Indications for use
The EVOLUTION® Cement Keel is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques The EVOLUTION® Cement Keels are for cemented use only.

Source page: https://510kreport.com/device/K231947
Methodology: https://510kreport.com/methodology