Swiss family-owned Medacta International has received clearance from the FDA to market its Anatomic Shoulder and Reverse Shoulder components of its modular shoulder system in the U.S.
The company also announced on October 26, 2017 that the first surgery in the U.S. of the device was performed by Matthew Saltzman, M.D., associate professor of orthopaedic surgery at the Northwestern Memorial Hospital in Chicago, Illinois.
Saltzman said the procedure “went very well.” He added that the system’s instrumentation and implants allow for “impressive anatomic restoration, resulting in an efficient surgery and, hopefully, improved patient outcomes.”
The company says the system features a broad range of options, including wide-ranging sizes, adjustable offset, and innovative configurations developed by an international team of expert surgeons. The platform, states the company, “offers modularity and compatibility…while still respecting anatomic conversion from primary to reverse.”
Predicates and Indications
The clearance notification for the reverse shoulder was filed in February 2017 and revised in early September. The primary predicate device was DePuy Orthopaedics Inc.’s Delta Xtend Reverse Shoulder System and Modular Stem.
The device is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement and a grossly rotator cuff deficient shoulder joint.
The anatomic shoulder notification was filed on July 17, 2017. The primary predicate device was Synthes’ Epoca Shoulder Prosthesis System.
The device is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The shoulder system was unveiled in February 2017 following its first ever surgery in Europe.
I currently have a shoulder with the ball on the lower part of the arm. I have had it for 13 years and have been experiencing pain. My surgeon look at the X-Ray sand said the bone beneath the socket is deteriorating and will have to be replaced when the pain becomes unbearable. Seeing this article, I was wondering if this reversal type of device is for me. I am trying to anticipate what I will need. ..Leonard Lackey.