# K262293: EVOLUTION MPX™ Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Microport Orthorecon Co., Ltd.
- Decided: Sep 10, 2026 after 65 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: 1 generation back to K093552 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093552: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2010) Summary page 5.

## Indications for use
The EVOLUTION MPX™ Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory 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 MPX™ Total Knee System is for cemented use only.

Source page: https://510kreport.com/device/K262293
Methodology: https://510kreport.com/methodology