Actera Hip System Gains 510(k) Clearance
Actera Hip System, made by Conformis, has received 510(k) clearance from the FDA.
The device offers a minimally invasive approach similar to direct anterior hip replacement plus easier access to the femur and consequently less injury to muscles and fewer potential interactions with nerves, Conformis said.
The device features a tri-taper femoral stem design, which is becoming more common among orthopedic surgeons, according to the company.
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, noted the company.
Due to their shorter length and curved distal bullet tip, these implants are more easily inserted and positioned through since they require less proximal surgical exposure than is required for insertion of a longer hip implant.
The Actera Hip System will be introduced under a limited market release in certain U.S. markets in the coming months.