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The Instratek Sub-Talar Lok arthroereisis implant restricts excessive subtalar pronation in all three planes, providing for a more normal subtalar joint motion in patients. The Sub-Talar Lok is intended for the following pathological conditions resulting from disease, injury, or other trauma.

• Hypermobile pes valgus
• Posterior tibial tendon dysfunction
• Severe pronation
• Subtalar instability
• Hypermobile flexible congenital flat foot

The Instratek Sub-Talar Lok Implant is designed to stabilize the subtalar joint of the hyperpronated foot. The implant is conical shaped with external threads of uniform depth and pitch. The device is cannulated for use with a guide wire. The product will be provided with a procedure kit containing: Five (5) dilators sized 7 through 11 mm Ten Sub-Talar Lok implants, two each of five sizes Regular driver, 4.3mm hex head Rescue driver, threaded

This submission is for a medical device (Sub-Talar Lok Implant), not an AI/ML device. Therefore, the requested information regarding AI/ML device performance, acceptance criteria, study design, expert involvement, and training/test set details is not applicable.

The document describes the device's technical characteristics and intended use within the context of a 510(k) summary for substantial equivalence to legally marketed predicate devices. The approval is based on a comparison of design, materials, intended use, and technological characteristics to existing devices, implying that the device meets acceptance criteria through this demonstration of substantial equivalence rather than a specific performance study with quantitative metrics and ground truth as would be required for an AI/ML product.

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