HUNTLEY, Ill.--Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance to the TARSA-LINK Bunion Correction System. The TARSA-LINK Bunion System is the first stand-alone opening base wedge with built-in fixation on the market. It is utilized for internal bone fixation for bunionectomies, opening base wedge osteotomies, bone fractures, fusions, or trauma.
“The TARSA-LINK Bunion System vastly improves the standard of care for opening base wedge osteotomy patients,” said Rich Mueller, Chief Operating Officer for Life Spine. “In past opening base wedge osteotomies, a plate and screws were placed on the outside of the first metatarsal for fixation. This type of construct can be irritating post-operatively by protruding against footwear. The TARSA-LINK Bunion System has built in fixation and sits flush within the bone, reducing the possibility of site irritation. This stand-alone system also reduces procedure time and offers stabilization equivalent to traditional constructs.”
The TARSA-LINK Bunion System is the sixth 510(k) clearance in a year, joining Centric Medical’s portfolio which includes innovative osteobiologic products. It is one of seventeen patents pending in Centric’s portfolio including the clearance last week of the state-of-the-art Hammertoe Correction System. The TARSA-LINK Bunion System is scheduled for release in the fourth quarter this year.
“The TARSA-LINK Bunion System vastly improves the standard of care for opening base wedge osteotomy patients”
Rich Mueller, Chief Operating Officer for Life Spine