Search Results

The Bolo Button System is intended to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

The Bolo Button System consists of two syndesmosis buttons made of titanium alloy (Ti6AI4V ELI (ASTM F136)) and suture tape (Ultra High Molecular Weight Polyethylene Suture (UHMWPE) (ASTM F2848)). It is intended for fixation of syndesmotic injuries in an ankle fracture. The system offers two lateral button sizes. One fits 1.5mm suture tape and the other fits 2.0mm suture tape. Both share the same medial button. System instrumentation includes: drill bits, K-wires, tissue protector, and an inserter which deploys the implants. The implants and associated instrumentation are supplied sterile. This is a single use system.

This document is a 510(k) premarket notification for a medical device called the Bolo Button System. It is not for an AI/ML device. Therefore, the questions regarding acceptance criteria and studies for an AI/ML device are not applicable to the provided document.

The document states:

• "No clinical studies were performed"
• "Non-clinical Test Summary: Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering rational along with static and dynamic testing was performed to show substantial performance equivalence. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified above."

The criteria and study described are for demonstrating substantial equivalence of a physical medical device (Bolo Button System) to its predicate devices based on design, materials, and mechanical performance, not for the performance of an AI/ML algorithm.

Ask a specific question about this device