Panther Orthopedics, Inc. Receives FDA 510(k) Clearance for the PUMA System(TM) - An Orthopedic Flexible Fixation Device
Published: Mar 07, 2018
TAIPEI, Taiwan, March 7, 2018 /PRNewswire/ -- Panther Orthopedics, Inc., a San Jose, California medical device company, announces today that the company has received U. S. Food and Drug Administration 510(k) clearance for the PUMA SystemTM, an implantable flexible fixation device indicated for Syndesmosis Fixation, Hallux Valgus Reconstruction, and Tarsometatarsal Fixation. The PUMA SystemTM represents a revolutionary advancement in the treatment of orthopedic injuries by allowing normal anatomical motion of the joint while maintaining continuous compression.
"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," said Kathy Stecco, M.D., CEO and Co-Founder of Panther Orthopedics. 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.
CONTACT: Kathy Stecco +1-408-930-3332
SOURCE Panther Orthopedics, Inc.