K243574
- 510(k) number
- K243574
- Device name
- Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
- Applicant
- Microport Orthopedics, Inc. TN · US
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2025-02-18
- Date received
- 2024-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243574.pdf
Official FDA record: K243574
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.