Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, has announced the U.S. FDA 510(k) clearance of its TARSA-LINK Bunion Correction System, the first stand-alone opening base wedge with built-in fixation on the market.
The Tarsa-Link bunion correction system is utilized for internal bone fixation for bunionectomies, opening base wedge osteotomies, bone fractures, fusions, or trauma. The system’s associated implant is made from a PEEK material, which provides greater stability than an allograft, while eliminating the risk of donor graft rejection. The implant’s design facilitates the use of screws that can be placed through the wedge, locking in the correction while providing a stable environment for fusion
Based in Huntley, Illinois, Centric tells us this is its sixth 510(k) clearance in a year, joining a 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 company says its 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,” 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.”
Source: Business Wire