The FDA gave Conformis' Actera hip system 510(k) clearance, the devicemaker said Sept. 13.
Actera uses a tri-taper femur system stem for direct anterior approach total hip replacements, according to a company news release. The system aims to facilitate a minimally invasive approach with easier access to the femur and less injury to muscles.
"Surgeons have demonstrated a significant and growing preference for anterior total hip arthroplasty surgeries in recent years, and the innovative tri-taper stem is designed for easier placement," Conformis CEO Mark Augusti said in the release. "Peer-reviewed studies provide an increasing body of evidence that a tri-taper stem supports improved proximal load transfer and lower likelihood of implant loosening."
The system will be introduced in the U.S. as a limited release.