INHANCE Gains FDA Clearance for Reverse Total Shoulder Replacement

By Julie A. Vetalice

INHANCE Gains FDA Clearance for Reverse Total Shoulder Replacement

The INHANCE™ Shoulder System from DePuy Synthes received FDA 510(k) clearance for use in reverse total shoulder arthroplasty. This clearance is in addition to the system’s already cleared use in anatomic shoulder arthroplasty.

Features of the reverse system include:

  • 135° neck shaft angle with lateralized options
  • Sizing options to address a full range of patients
  • 3D laser-printed R/SPEED™ Baseplates and Modular Baseplates with Central Screw and Central Post options
  • Advanced cross-linked Vitamin E polyethylene for desired wear characteristics and oxidative stability
  • ONE STEP PREP™ Glenoid Reamers

The INHANCE Shoulder System is also designed for the shift in site of care of certain orthopedic procedures toward outpatient and ambulatory surgery centers. INHANCE implants are designed to preserve bone, provide immediate and biological fixation, and facilitate intra-operative flexibility while simplifying preparation for various surgical treatment options.

“Adding the reverse total shoulder arthroplasty to our INHANCE Shoulder System is helping us transform patient care,” said Rajit Kamal, Worldwide President, Sports Medicine & Shoulder Reconstruction, DePuy Synthes. “This reinforces our commitment to innovation that addresses the most pressing needs of surgeons today and the market dynamics driving clinical trends of tomorrow.”

Source: DePuy Synthes

 

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory