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Universal Tendon Spacer is a medical device used in the reconstruction of the flexor and extensor tendons of the hand. The device is implantable for 2 to 6 months and intended for single use. This device is used for: Adherent or mutilated tendons following trauma or a primary repair which has failed. Absence of the tendon sheath. Non-functioning, mutilated or adherent tendon pulleys. Ruptured tendons. The patient must be in good health with sufficient tissue cover. Sufficiently healthy joints, bone marrow and adequate vascular and neuro-muscular conditions are also necessary to facilitate a definite functional improvement using this reconstruction technique. The patient must be cooperative, especially concerning the need for rehabilitation measures.

Universal Tendon Spacer (UTS) is a medical device made of silicone for temporary implantation (two to six months) for use in the twostage reconstruction of the flexor and extensor tendons of the hand. When implanted, UTS is in contact with the tissues and bones of the fingers for a long-term contact duration (>30 days). This medical device contributes to the rehabilitation of the digital canal by creating a neo-sheath which should be as large as possible depending on the patient's anatomy. It is the body with the silicone which makes it possible to obtain the synovial neosheath which will receive, during the second operative time, a tendon of the formation of this neo-sheath the tendon will be able to slide again in the sheath and will make the finger of the patient work. The Universal Tendon Spacer is a single size ovoid-shaped rod whose over its entire length. The rule is for the larger diameter to always be twice that of the smaller diameter. The principle is the same as those of rival man difference being that the four different sizes generally provided are all available on one single rod. The UTS is made of long-term nigh performance implantable silicone to which barium sulfate has been added to make the rod radio-opaque for X-ray examination. Raw materials of Universal Tendon Spacer meet USP Class VI test requirements. Only one reference exists for this device, and it is not intended to be assembled with any other device. The intended patient population is adults and children. The device is for single use only and is provided sterile.

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.