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The PDO Max Suture with Dual Needle is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

The synthetic barbed Sutures are made of polydioxanone (PDO) with needles attached to each end of the suture. The needles are straight and pre-loaded onto each end of the suture filament. The pigment for the violet dye is D&C Violet No.2. The sutures are inserted into the tissue using the needles. Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament. The suture is barbed into two sections and each section are in opposite direction. The device is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. The Synthetic Absorbable suture with needle, approximate tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues. The suture is available in 2-0, 0 and 1, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP). The needles are 50mm in length (each) and are reverse cutting type.

The PDS Barbed Surgical Suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

PDO MAXX THREADS™ barbed sutures are made of polydioxanone (PDO) and have the colorant D&C Violet No. 2 (21 CFR 74.3602). The sutures are USP 0 suture in diameter and USP 2-0 suture in tensile strength, and 150 mm in length, swaged to a 19G/100 mm "L" Blunt needle and preloaded in a needle cannula. The sutures are inserted into the cannula/needle. The barbed sutures have cut barbs along the axis of the monofilament that allows the suture to embed in the tissue after the surgeon has placed it; therefore, there is no need to tie a surgical knot. The sutures are absorbable in the body.