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Synthes Bioresorbable Suture Anchor is intended to repair ligamentous and tendinous defects in the shoulder, knee, foot, ankle, hand and wrist.

Synthes Bioresorbable Suture Anchors are injection molded from the poly(L/DL-lactide). Synthes Bioresorbable Suture Anchor is cylindrical in shape, ranges from 5.0 mm - 20.0 mm in length, has an outside diameter of 3.5 mm, and has a thread with metric profile. It is recommended to use a commercially available non-resorbable size #0, #1, or #2 USP suture in combination with this device. The Bioresorbable Suture Anchor has a drive mechanism which facilitates an interference fit of the device onto the suture anchor driver.

The provided text is a 510(k) Summary for the Synthes Bioresorbable Suture Anchor, a medical device for repairing ligamentous and tendinous defects. The summary details the device's classification, predicate devices, description, and intended use. The FDA letter confirms the substantial equivalence of the device to previously marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, study designs (such as sample sizes, data provenance, number of experts, adjudication methods), or ground truth establishment relevant to an AI/ML medical device. The document is a regulatory submission for a physical implantable medical device, not a software-as-a-medical-device (SaMD) or an AI-enabled diagnostic tool. Therefore, the requested information cannot be extracted from this text.

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