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The Surgimatix Absorbable Fixation System is indicated for the approximation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

The Surgimatix Absorbable Fastener System is designed to deliver an absorbable fastener for tissue-to-tissue fixation or mesh-to-tissue fixation during surgical procedures. The deployment device consists of an ergonomic handle with trigger, shaft and tip. The shaft is 38 cm long, and can be utilized for laparoscopic or open surgical procedures. The device is preloaded with 20 polydioxanone absorbable fasteners. During deployment into soft tissue or mesh the absorbable fastener is formed into a helical configuration to establish fixation.

Surgimatix ProxiFast Absorbable Staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin with an approximate thickness of 1 to 5 mm where an absorbable tissue fastener is desired for temporary tissue approximation. The device is not indicated for use in shallow or very small incisions, and is not indicated for final closure of the terminal 2 cm of incisions.

The ProxiFast Absorbable Staple is an absorbable staple for subcuticular skin closure. The staple is made of polydioxanone, and consists of a main body that is 19.35 mm in length, with an obround loop at either end, each of which measure 2.74 by 4.72 mm. The staple is formed into an s-shape the size of 10.3 mm x 17.3 mm prior to deployment, and forms a helical configuration when placed into the subcuticular skin. The Proxifast Absorbable staples are used in conjunction with a manual surgical stapler from Surgimatix, Inc. (Note: The Surgimatix manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).