Panther Orthopedics said today it won FDA 510(k) clearance for its Puma implantable flexible fixation device.
The newly cleared device from the San Jose, Calif.-based company is now indicated for syndesmosis fixation, hallux valgus reconstruction and tarsometatarsal fixation. The system allows for a 2.8 mm pilot hole to preserve bone tissue and comes in a single size, the company said.
“The Puma System is a unique technology that provides stabilization of the joint with a consistent force, allowing rotational flexibility without displacement or creep,” Dr. Kenneth Hunt of the University of Colorado Department of Orthopaedics said in a press release.
Panther Orthopedics said it is developing dynamic fixation solutions for orthopedic trauma and sports medicine applications, and that it closed a Series A investment led by Medeon Biodesign last March.
“The Puma System was designed to solve the problems experienced with the use of stiff metal screws which serve as stress risers and prohibit normal physiological joint motion and with flexible fixation devices that creep and therefore lose compression,” CEO & co-founder Dr. Kathy Stecco said in a prepared statement.