Why is this important?
Reason #1 - The "Breakthrough Device Designation" is new for Orthopedics. Active Implants is either the 1st or 2nd ortho company to ever to receive this designation. (see chart)
TO:Distribution of granted breakthrough device designation requests across common clinical specialties and medical device areas.
Reason #2 - Historically, the "Breakthrough Device Designation" yields a higher clearance rate (see chart)
TO: Summary data for breakthrough device designation requests.
Read below the FDA’s 2018 report to Congress about the Breakthrough Device program.
Congress-Report-Breakthough-Devices-Program-1Download
Read below the FDA’s Breakthrough Device guidance document. The advantages for devices designated as a Breakthrough Device are on pages 3 to 6.
Breakthrough-Device-Guidance-Document-2018-12-18-1Download
First 'Artificial Meniscus' wins FDA Breakthrough Device Designation (MDDI by Amanda Pedersen)
The designation allows an expedited review of the NUsurface meniscus implant from Active Implants.
U.S. patients who continue to suffer from knee pain after meniscus surgery, but are too young for total knee replacement may soon have ...
