US FDA okays AdvantageRib SystemApril 9, 2019
SIG Medical said the US FDA has granted 510(k) clearance for its enhanced AdvantageRib System, K183317.
This product marks the third rib fracture 510k that SIG Medical is commercializing.
The latest 510k features new implants to treat patients along the entire spectrum of bone quality and modifications to existing implants to improve surgeon experience.
AdvantageRib, in a limited market release, has been utilized in over 50 rib fractures with the first patient treated nearly 2 years ago.
SIG Medical plans to make AdvantageRib available nationwide. The US full market launch is slated to occur at the 2019 Chest Wall Injury Society (CWIS) Annual Meeting where the leading experts gather to focus on operative care of patients with chest wall injuries.