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The Arthrex Bio-Button is intended for the suture fixation of soft tissue to bone, utilizing the Arthrex® Corkscrew™ Suture Anchor, and polyester braided sutures appropriate to the procedure, up to size 5 (single strand). This product is intended for use in repairing rotator cuff tears.

The Bio-Button is a PLA disc consisting of four holes for passing suture. Once suture is passed through the soft tissue, the two free ends of the suture are brought through the Bio-Button in any two holes. Soft tissue reattachment is accomplished by tying the suture ends over the Bio-Button securing the suture and disc to the bone.

This 510(k) premarket notification describes a medical device, the Arthrex Bio-Button, which is a soft tissue fastener. It does not contain information about the device's acceptance criteria, reported performance, or any studies to prove it meets acceptance criteria, as these are typically found in the body of the 510(k) submission, not the summary or FDA's response letter.

Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on the device description, intended use, and substantial equivalence to a predicate device for regulatory clearance.

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