EVOLUTION MPX Total Knee System— 510(k) K262293
Substantially EquivalentSuzhou Microport Orthorecon Co., Ltd.
FDA 510(k) clearance K262293 for EVOLUTION MPX Total Knee System, Substantially Equivalent on 2026-09-10. Applicant: Suzhou Microport Orthorecon Co., Ltd.. Device class: 2.
Summary
The EVOLUTION MPX Total Knee System is a knee replacement under JWH, semi-constrained cemented knee prostheses with polymer/metal/polymer construction. EVOLUTION is a known medial-pivot knee brand. The record doesn't define what "MPX" adds.
Class II, 21 CFR 888.3560. The Orthopedic panel reviewed it as a Traditional 510(k).
Suzhou MicroPort OrthoRecon filed from Suzhou, China. Review took 65 days (July 7 to September 10, 2026), fast for a total knee system. Filings that build on an existing knee design family often move quickly.
Clearance details
- Applicant
- Suzhou Microport Orthorecon Co., Ltd.
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code JWH
view allMore clearances from Suzhou Microport Orthorecon Co., Ltd.
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.