Vanguard SSK 360 Revision Knee System
510(k) K121149
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121149 | Date16 May 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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, 23 Sep 2026
The Vanguard SSK 360 Revision Knee System is an orthopedic knee prosthesis system designed for revision knee reconstruction. It includes updated splined knee stems intended for cemented fixation to provide additional stability to femoral or tibial knee components where needed. The system allows for independent sizing of femoral and tibial components and offers the capability to position the universal femoral and tibial stem offsets in a full 360-degree range for intraoperative flexibility.
This device is supplied by Biomet Manufacturing Corp and was authorized under FDA 510(k) clearance with a substantially equivalent decision. It is intended for use in revision knee surgery where customized implant combinations are required. The system includes splined knee stems and is designed to be used with cemented fixation. No specific information on sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the available data.