Univers Revers Shoulder Prosthesis System
510(k) K130129
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130129 | Date31 May 2013 | StatusActive |
Official records
- FDA 510(k) database K130129
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Univers Reverse Shoulder Prosthesis System is a reverse shoulder arthroplasty device designed for patients requiring total shoulder replacement. It features a modular design with a 135-degree neck-shaft angle to enhance range of motion and reduce scapular notching, while an inlay humeral design ensures proper soft-tissue tensioning. The system includes options for screw or post fixation, augments, and multiple glenoid lateralization choices to accommodate various anatomical needs. This device is classified under orthopedic implants for shoulder arthroplasty and is intended for surgical use in qualified medical settings.
The system is supplied as a sterile, single-use implant intended for surgical implantation by orthopedic surgeons. It includes a press-fit stem and modular glenoid components, with additional features for fracture repair such as press-fit and long-stem options. The device is regulated under the FDA’s 510(k) pathway, with clearance granted as substantially equivalent to predicate devices. Storage and handling must comply with sterile surgical instrument protocols, and its modularity allows for intraoperative adjustments to optimize fit and function.