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Apex® Pins are intended for use in conjunction with external fixators in children and adults. Specific indications include, but not limited to the following conditions: bone fracture fixation for open, closed and/or unstable fractures, osteotomies, arthrodeses, deformity correction including bone transport, revision procedures where other treatments or devices have been unsuccessful or bone reconstruction procedures. The pins will be available with and without hydroxylapatite (HA) coating.

This submission is a line extension to the Apex® Pin product line to include fixation pins coated with hydroxylapatite (HA) to improve purchase in osteoporotic bone and for use in long-term fixation to reduce the incidence of pin loosening by enhancing the fixation at the pin-bone interface. The Apex® Pins are external fixation pins used with external fixators for fracture fixation. They are intended to be used with the other components in Howmedica Osteonics' external fixation systems.