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KMI receives FDA market clearance for K2 Hemi Toe Implant System
San Diego | Friday, April 4, 2003, 08:00 Hrs  [IST]

Kinetikos Medical Inc (KMI), a company specializing in small bone medical devices, announced the launch of the K2 Hemi Toe Implant System, a one-piece surface replacement system for the "big toe" (the proximal phalanx of the first metatarsophalangeal joint, or the first MPJ) during the annual Midwest Podiatry Conference, being held in Chicago April 3-6.

Just cleared to market by the FDA, the K2 Hemi Toe Implant System is a metallic, one-piece surface replacement system. In development and testing for over two years, it is indicated for use in cases of painful loss of motion due to osteoarthritis of the first MPJ, hallux rigidus/limitus, and end stage hallux valgus with bunion deformity.

"Most people don't spend much time thinking about life without a big toe, but we aren't able to stand, to balance or walk, let alone climb stairs without them," says James F. Ham, President of KMI. "We are happy to enhance the quality of life for patients who have lost use of the MPJ, and who previously had few options to improve greater motion, flexibility and durability."

The K2 Hemi Toe Implant System more closely mimics the natural human anatomy than its component-toe-replacement counterparts and allows re-attachment of the flexor tendon. The system also offers metatarsal head remodeling, which creates a congruent articulating surface between the implant and the metatarsal head by removing excess loose cartilage and bone. Compared to total toe fusion and total joint replacement, it provides patients with greater motion, is less invasive and less costly than other surgical procedures.

Anatomically designed to match the shape of the proximal phalanx, the K2 Hemi includes a slight groove in the base to accommodate the flexor hallucis longus (FHL) tendon. The unique design of the implant also includes a suture hole, which enables the FHL tendon to be sutured to the implant, and to the base of the proximal phalanx, in effect creating a tendon transfer of the FHL that adds flexor power to the proximal phalanx.

"Because only a part of the toe is removed during surgery, the K2 Hemi Toe Implant System is less invasive and removes less bone," continued Ham. "Therefore, recovery is also less traumatic."

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