DESCRIPTION: TEKMON is sterile synthetic, absorbable surgical monofilament suture. The suture is made of Poly(glycolide-co-caprolactone) and the empirical formula is (C2H2O2)m(C6H10O2)n. Poly(glycolide-co- caprolactone) copolymer has been shown to be non-antigenic, non-pyrogenic and elicits only a slight tissue reaction during absorption. TEKMON sutures are dyed by D&C Violet No.2 (C.l. # 60725) during polymerization to enhance visibility in tissue. Sutures are also available in undyed form. TEKMON meets all requirements for synthetic absorbable surgical monofilament sutures specified at the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).

INTENDED PURPOSE: TEKMON sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular, neurological tissues, microsurgery or ophthalmic surgery.

TEKMON surgical sutures are single-use devices.

CLINICAL PERFORMANCE CHARASTERISTICS: TEKMON elicits a minimal initial inflammatory reaction in tissues and is eventually replaced with an in-growth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of TEKMON sutures occurs by means of hydrolysis, where the polymer degrades to the adipic acid which is subsequently absorbed and eliminated by the body. Absorption begins as loss of tensile strength followed by a loss of mass. Absorption test in rats and in vitro hydrolysis show that TEKMON retains approximately 60% of the original strength at 7 days post implantation. At two weeks, approximately 30% of the original strength is retained. Absorption is essentially complete between 90 and 120 days.

CLINICAL BENEFIT: TEKMON sutures provide secure soft tissue approximation and/or ligation in general soft tissue operations where an absorbable material is indicated. TEKMON sutures elicit minimal acute inflammatory reaction in tissue and ingrowth of fibrous connective tissue when used as intended.