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The Aesculap Resorbable Pin is intended for use in the fixation of fragments of non-load bearing bones, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.

The Aesculap Resorbable Pin is a small orthopedic fixation pin made from a copolymer material (Poly-L,DL -Lactide Co70/30) that is absorbed into the body over time.

The provided text is for a 510(k) summary for the Aesculap Resorbable Pin. This document indicates that no applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (Arthrex Meniscal Dart System and Bionx Smart Nail).

Therefore, there is no performance data or study described in the provided text that establishes acceptance criteria or proves the device meets specific performance criteria. The clearance is based on the claim of substantial equivalence to existing devices, implying that the safety and effectiveness are considered comparable based on the established profile of those predicate devices.

As a result, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided 510(k) summary for this particular device.

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