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The RC Buttress is intended for use to protect the suture during its use in transosseous bone tunneling in the repair of rotator cuff tears of the shoulder. The RC Buttress prevents the suture from pulling through the bone bridge between adjacent suture holes.

The RC Buttress is made of LactoSorb®, which is comprised of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. The LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs In Vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue.

The provided text is a 510(k) summary for the RC Buttress device, which is intended to protect sutures during rotator cuff repair. This document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Description: The RC Buttress is made of LactoSorb®, a bioresorbable and biocompatible polymer.
• Intended Use: To protect the suture during transosseous bone tunneling in rotator cuff repair, preventing suture pull-through.
• Regulatory Information: It includes the submitter's details, product code, device name, and the FDA's 510(k) clearance letter (K991009) confirming substantial equivalence to a predicate device. This clearance is based on the device's indications for use and general controls provisions of the Act.

Therefore, I cannot provide the requested information, as it is not present in the provided text. The submission is a regulatory clearance document, not a detailed study report with performance metrics.

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