Ziptek Receives FDA 510(k) for ZipE Knotless Tissue Repair

By Julie A. Vetalice

Ziptek received FDA 510(k) clearance to market the ZipE® knotless tissue repair and attachment device.

The absorbable button works like a zip-tie, obviating the need to make knots in small spaces, and is designed to disperse pressure across a large surface area and prevent the suture from tearing through tissue.

Internal testing results indicate that ZipE may offer improved healing rates by providing the most resistance to rip-through, the least gap formation, the most contact surface area and homogeneous contact pressures.

Source: Ziptek LLC

Other knotless repair devices in recent news:

  • KFx Medical entered into a license agreement with ConMed addressing patents used in knotless double row rotator cuff repair.
  • Ethicon and DePuy Synthes commenced U.S. launch of wound closure kits customized for orthopaedic surgery, including STRATAFIX™ Knotless Tissue Control Devices and the DERMABOND® PRINEO® Skin Closure System.

 

Product Labels: Orthobiologic Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory