The system is used for internal bone fixation for bunionectomies, opening base wedge osteotomies, bone fractures, fusions, or trauma.
Centric Medical said that the system is the first stand-alone opening base wedge with built-in fixation on the market.
Life Spine COO Rich Mueller said: “The TARSA-LINK Bunion System vastly improves the standard of care for opening base wedge osteotomy patients.”
“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 clearance for the TARSA-LINK Bunion System marks the sixth 510(k) approval from the FDA for the company in a year.
The system, which will be released in the fourth quarter of this year, is one of seventeen patents pending in Centric’s portfolio.
Earlier this month, Centric Medical has received 510(k) clearance from the FDA for its Hammertoe correction system.
Hammertoe system enables the implant to remain within the bone, helping in avoiding the follow up surgery to remove the pin.
Huntley, Illinois-based Centric Medical, a subsidiary of Life Spine, is engaged in the development of surgical implants for the treatment of distal extremity pathology.
