Panther gets FDA nod for bone fixation device

March 9, 2018  Source: FierceBioTech 204

Panther Orthopedics has won FDA approval for its implantable orthopedic fixation device. The 510(k) nod clears Panther to sell a device designed to deliver continuous compression during bone healing while allowing joint motion. 

San Jose, California-based Panther has picked up approval for use of the device in syndesmosis fixation, hallux valgus reconstruction and tarsometatarsal fixation. Panther thinks the device, called the Puma System, offers advantages over implants currently used in the treatment of these conditions.

“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,” Panther CEO and co-founder Kathy Stecco, M.D., said in a statement.

Panther made headlines 12 months ago when it unveiled a series A round led by Taiwanese medical device company Medeon Biodesign. But while that suggests a rapid path to market, the initial work on the bone fixation device goes further back. Patents that list Stecco as an inventor and Panther as the assignee date back to 2015.

The Puma System is the fruit of Panther’s work to use the Series A funds to develop devices for use in the treatment of orthopedic trauma and sports medicine.

By Ddu

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