Stem Extension Line (U2 Total Knee System – PSA Type)
by United Orthopedic Corporation
510(k) K252725
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252725 | Date25 Sep 2025 | StatusActive |
Official records
- FDA 510(k) database K252725
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- Withdrawn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, 18 Sep 2026
The Stem Extension Line (U2 Total Knee System – PSA Type) is a semi-constrained, cemented total knee prosthesis designed for orthopedic revision procedures. It features metallic femoral and tibial components with straight stems incorporating cross-slot geometry, providing structural support for bone loss or instability in the knee joint.
This device is intended for use in clinical settings by orthopedic surgeons, offering stem lengths ranging from 75mm to 200mm and diameters from 10mm to 24mm. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K252725) and falls under the Orthopedic advisory committee classification. No sterility or MRI safety information is specified in the provided data.
From the manufacturer
The U2 PSA (Posterior Stabilized Augmentable) Revision Knee system can be used with various augments and extension stems to restore joint stability and address bone loss, allowing surgeons the possibility for an optimal solution for each individual patient.
Manufacturer's product page: Knee System