FDA clears ArthroCare's Spartan 6.5 Needled Anchor

ArthroCare® Corp. (NASDAQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Spartan™ 6.5 Needled Anchor (Spartan). The Spartan device is a preloaded threaded anchor indicated for use in fixation of soft tissue to bone, such as during a rotator cuff repair. The needled version is utilized for open repairs, whereas the non-needled version, for which FDA clearance has previously been received, is for arthroscopic repairs.

The Spartan anchor complements ArthroCare's line of anchors which can be used with ArthroCare's suture passing technology, such as the FirstPass® suture passer. It has a unique 6.5mm, screw-in design and can be used to perform single and double row repairs. A 5.5 mm version previously received FDA clearance, as announced on February 15, 2011. The Spartan anchor is manufactured from PEEK, (polyether-etherketone), a material widely used in orthopedic implants. More than 400,000 patients undergo rotator cuff surgery annually in the U.S.

Source:

ArthroCare

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