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The MODUS System Self-drilling Screws are intended for use in the internal fixation in the craniofacial skeleton, secondary to trauma, reconstruction, or surgical correction of dento-facial deformations. The MODUS System Self-drilling Screws are intended for use in the internal fixation in the craniofacial skeleton, secondary to trauma, reconstruction, or surgical correction of dento-facial deformations which require positional and functional stability.

The MODUS® System Self-drilling Screws are self-tapping self drilling screws for use with the cleared MODUS plates and mesh fixation components. The screws are made from CP titanium, Grade 4 or titanium alloy. The screws are available in lengths ranging from 3 mm to 8 mm and diameters ranging from 1.2 to 2.0 mm.

This document is a 510(k) Summary for the MODUS® System Self-drilling Screws, seeking clearance from the FDA. It does not describe acceptance criteria or a study proving that the device meets acceptance criteria.

Instead, it asserts substantial equivalence to predicate devices based on:

• Intended Use: The MODUS Self-drilling Screws have the same intended use as predicate devices: internal fixation in the craniofacial skeleton due to trauma, reconstruction, or surgical correction of dento-facial deformations.
• Material: The screws are composed of commercially pure Grade 4 titanium or titanium alloy, similar to predicate devices.
• Design: The design, including a tapered thread for self-drilling capability, is stated to be the same as several predicate self-drilling screws.

The FDA's letter (pages 2-3 of the provided text) confirms that the device is deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This clearance process for medical devices often relies on demonstrating substantial equivalence to existing devices rather than requiring new clinical trials that establish acceptance criteria and prove performance against them, especially for devices and indications that are well-established.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies cannot be extracted from the provided text because these types of studies were not conducted or reported for this 510(k) submission. The basis for clearance was a comparison to predicate devices, not de novo testing against specific acceptance criteria.

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