Implantable Sleeve that Holds Spinal Screws in Place Gets FDA Clearance

Woven Orthopedic Technologies’ implantable sleeve to aid in screw fixation for spinal surgeries has received FDA’s 510(k) clearance.

The Implant Enhancement System is designed to address a common challenge in orthopedic and spine surgery, the ability to “more confidently use surgical screws when operating in compromised fixation scenarios,” the company said.

The off-the-shelf device can be deployed in under two minutes and can be used with a wide range of screw systems from a variety of suppliers. “It's very similar to anchors used in construction to secure screws in fragile plaster and drywall,” the company said.

Already certified for use in Europe, the device will be made available in staged, regional releases in the U.S.