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Panther Orthopedics gets FDA 510(k) clearance for PUMA system

Panther Orthopedics has received 510(k) clearance from the US Food and Drug Administration for the PUMA System, an implantable flexible fixation device indicated for syndesmosis fixation, hallux valgus reconstruction, and tarsometatarsal fixation.

The PUMA System represents a revolutionary advancement in the treatment of orthopedic injuries by allowing normal anatomical motion of the joint while maintaining continuous compression.

Panther Orthopedics CEO and co-founder Dr Kathy Stecco said: "The PUMA SystemTM 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.

The PUMA SystemTM allows for a 2.8 mm pilot hole that preserves bone tissue and comes in one size for a simple, customized approach that can be trimmed to the specific anatomy in order to provide stable dynamic fixation of the joint.

"The PUMA SystemTM is a unique technology that provides stabilization of the joint with a consistent force, allowing rotational flexibility without displacement or creep," said Kenneth Hunt, M.D., Associate Professor and Chief of Foot and Ankle, University of Colorado Department of Orthopaedics.

Panther Orthopedics, Inc. is developing next level dynamic fixation solutions for orthopedic trauma and sports medicine applications.

 The company successfully closed on a Series A investment led by Medeon Biodesign, Inc. in March 2017.