FDA Clears Continuous Compression Extremity Device
San Jose-based Panther Orthopedics, Inc.’s, flexible extremity joint fixation device has been cleared by the FDA for sale in the U.S.
The Puma System is indicated for syndesmosis fixation, hallux valgus reconstruction, and tarsometatarsal fixation.
While the FDA action is a clearance, meaning the device was essentially equivalent to a previously approved device, the company claims 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.”
According to a March 7, 2018 company announcement by Kathy Stecco, M.D., company co-founder and CEO, the 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.”
Kenneth Hunt, M.D., associate professor and chief of foot and ankle, University of Colorado Department of Orthopaedics, said the system is unique in that it “provides stabilization of the joint with a consistent force, allowing rotational flexibility without displacement or creep.”
The system allows for a 2.8mm pilot hole that preserves bone tissue and comes in one size for a simple, customized approach that can be trimmed to the specific anatomy to provide stable dynamic fixation of the joint, said the company.
The start-up company announced a Series A investment by Taiwan-based medical device company, Medeon Biodesign, Inc., about a year ago.
At the time, the company pointed to a need for better fixation products for both trauma and sports medicine in fracture fixation and joint stabilization applications that were still underserved.
“Current options for fixation include cortical screw and suture button flexible fixation devices. However, many limitations associated with currently marketed products are not being addressed,” said Stecco. “We have developed an innovative platform for dynamic extremity fixation, which we believe will provide continuous compression during the healing period while still allowing micromotion. The intuitive design of our solutions is easy to use and intended to eliminate the need for most second surgery removal, providing significant benefits for both the patients and the entire healthcare system.”
See More at the Source: Continuous Compression Extremity Device Cleared by FDA | Orthopedics This Week
by: Walter Eisner