Iconacy™ Receives FDA Clearance For I-HIP
ICONACY Orthopedic Implants announces FDA 510(k) clearance to market the I- Hip GT Femoral Stem System. This marks ICONACY’s third product clearance in 16 months.
The GT system was developed to give greater flexibility for matching patients varying vertical and horizontal offsets in addition to creating multiple options for incremental changes to both with any given femoral size.
“The development of products such as the I-Hip GT system demonstrates the talent of our engineering and surgeon developer team. They have taken a challenging issue in orthopedics and provided a simple solution. We look forward to having this great solution delivered to patients,” says Kevin Cox, VP of Sales and Marketing.
As noted in the indications for use, the I-Hip system consists of porous coated femoral stem and acetabular cup components intended for cementless, press-fit fixation.
ICONACY is an entrepreneurial orthopedic company started by seasoned professionals with a view focusing on the needs of patients, surgeons and hospitals without the bureaucracy and costly infrastructure of larger organizations. ICONACY will produce all of its product in the United States which will include hip, knee and shoulder joint replacements.