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Surgical indications for the Single Size Tendon Spacers include: Scarred or adhering tendons due to trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is single use, temporary implantation for 2 to 6 months.

The Single Size Tendon Spacer is designed to facilitate the two-step tendon reconstruction surgery. The device is 50 cm long, and its oval cross section increases progressively over its length from 3.0 x 1.5 mm to 3.0 mm. The spacer slope is designed to match shapes and dimensions of the digital canal. The spacers are made of high performance medical grade silicone elastomer containing barium suffate to provide radio-opacity. During the first stage of the reconstruction surger is placed into the reconstructed tendon bed and slid until optimum fit is achieved. The tendon is attached to the distal phalanx and the proximal spacer end is left free in the palm or forelimb. Excess spacer material is cut off. The second stage of surgery is performed 2 to 6 months later, once an appropriate pseudo-sheath has been created around the spacer, and tissues are soft and pliable. The spacer is then removed and replaced by a permanent active tendon autograft. The device is not intended as permanent implant or to function as a replacement for a ligament or tendon.