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The Fusion FibFix Nail is intended for use in the fixation of fibula fractures and osteotomies.

The Fusion FibFix Nail consists of a titanium alloy (Ti6AI4V ELI (ASTM F136)) intramedullary fibula nail and threaded bone fixation fasteners for fixation of the ankle following trauma and osteotomy. The system includes corresponding instrumentation to support both insertion and removal.

The Fusion FibFix Nail system includes intramedullary fibula nails, screws and end caps. Fibula nails are offered in 3.7mm, 4.7mm and 5.7mm diameters with lengths ranging from 130mm to 270mm. The included screws are offered in 2.7mm with lengths ranging from 10mm to 22mm.

When clinically indicated, the system may be used in conjunction with adjunctive rigid or flexible syndesmotic fixation. Flexible syndesmotic fixation is provided by the Bolo Button System (K242091), and rigid fixation may be provided with 3.5mm and 4.0mm screws cleared under by the PolyLock Plating System (K211843).

All implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: Drill bits, reamers, k-wires, percutaneous screw targeting system and guide wires.

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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.

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