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Synthes Ti Alloy HTO System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component.

Synthes Ti Alloy HTO System is an instrument and implant system. It utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The plates are available with an anatomically contoured head of the screw has a round cross section with a threaded conical underside to fit into the plate. The underside has a tapered thread to match the design of the holes in the plate. A standard 4.5 mm cortex screw and 5.0 mm locking screw are available for use with the plates.

This document is a 510(k) summary for a medical device (HTO System) and, as such, does not contain the kind of detailed study information (like acceptance criteria, sample sizes, expert qualifications, etc.) that would typically be found in a clinical trial report or a performance study.

The document states: "Based on the results of confidential testing, it is our opinion that the Ti Alloy HTO System is substantially equivalent to Howmedica's Alta Metaphyseal L-Plate." This indicates that the regulatory submission relies on comparison to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics for the new device as a standalone product.

Therefore, I cannot provide the requested information. The document does not describe acceptance criteria for device performance or a study proving it meets those criteria in the way a clinical study report would.

The information provided is primarily:

• Device Description: What the Synthes Ti Alloy HTO System is and its intended use.
• Comparison to a Predicate Device: It states the device is compared to "Howmedica's Alta Metaphyseal L-Plate and 3.7 mm Cortex Screws and 4.2 mm Cancellous Screws."
• Brief Surgical Insertion Steps: A high-level overview of how the device is implanted.

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