SIG Medical (Hershey, Penn.) has received FDA 510(k) clearance for its enhanced AdvantageRib System, the K183317.
The system is the third rib fracture system from SIG Medical that has received 510(k) clearance recently and is being commercialized. The most recent 510(k) includes new implants that treat patients, as well as the entire spectrum of bone quality and modifications to existing implants to improve patient experience, according to the company.
AdvantageRib is currently in a limited market release. It has been used in over 50 rib fractures and the first patient was treated almost two years ago.
SIG Medical now plans to make the AdvantageRib available across all of the U.S. next month at the 2019 Chest Wall Injury Society annual meeting.