Legion Stem With Holes
510(k) K072531
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072531 | Date6 Dec 2007 | StatusActive |
Official records
- FDA 510(k) database K072531
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JWH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Legion Stem With Holes is an orthopedic device classified as a femoral component for total knee arthroplasty. It is designed to be implanted within the femur during knee replacement surgery, providing structural support and stability to the knee joint. Constructed as a modular component, it integrates with other elements of the Legion Total Knee System to restore function and mobility. Its design includes perforations to facilitate bone ingrowth and fixation, ensuring long-term stability in cementless applications.
This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K072531) and falls under the Orthopedic advisory committee classification. The stem is compatible with MRI environments, though specific safety parameters should be confirmed with the manufacturer’s instructions. Storage requires adherence to sterile packaging guidelines, and its modular design allows for customization to match patient anatomy and surgical approach.