Synthes Sternal Fixation System
by Synthes (Usa) 510(k)
Active
510(k) K010943
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010943 | Date27 Jun 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JDQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3010
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Synthes Sternal Fixation System is a device intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. It consists of plate and screws for fixation of the anterior chest wall.
The system is supplied as a titanium-based fixation system and is regulated under FDA 510(k) clearance K010943 with product code JDQ. It was determined to be substantially equivalent to a predicate device and reviewed by the Orthopedic advisory committee.