Panther gets FDA nod for bone fixation device

San Jose, California, where Panther Orthopedics is based. (Tim Wilson/CC BY 2.0)

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 cofounder Kathy Stecco, M.D., said in a statement.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

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.

Suggested Articles

By employing heart rate signals, physical activity and sleep quality, common Fitbit trackers may be able to predict the spread of the flu.

Nanox has raised $26 million to help fuel the development and commercialization of its Star Trek-inspired digital X-ray bed.

Oncology is clearly a major medical and societal issue, but one that sees too much focus from biopharmas at the expense of other killers.