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The Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

The device description of the Meniscus Arrow™ is as follows.

• Composed of poly-L/D-polylactide copolymer
• Length 10, 13 and 16mm
• Diameter 1.1mm
  The dimensions and shape are completely identical with the Biofix® Biodegradable Meniscus Arrow System (K955768).

The provided text is a 510(k) summary for the Bionx Implants Inc. Meniscus Arrow™ and an FDA clearance letter. It clearly states the device's intended use and describes its similarities to a predicate device, the Biofix® Biodegradable Meniscus Arrow System (K955768).

However, this document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, adjudication methods, or specific details about training or test sets. Instead, the clearance for Meniscus Arrow™ is based on its substantial equivalence to the predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them from the provided text. The document focuses on demonstrating that the new Meniscus Arrow™ is fundamentally the same as its already-cleared predecessor.

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