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Synthes External MVMD is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.

Synthes External MVMD is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.

The Synthes External MVMD is a bone lengthening and distraction device which is achieved by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be achieved with this device after distraction.

The Synthes External MVMD is comprised of two interchangeable distraction arms, pin clamps, universal clamps, rods, flat head screws, and activation nuts. The pin clamps can accept 2.0 mm k-wires.

The provided text is a 510(k) summary for the Synthes External MVMD, a bone lengthening and distraction device. It primarily focuses on demonstrating substantial equivalence to a predicate device and receiving FDA clearance. It does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot provide the requested information based on the given document. The document's purpose is regulatory clearance, not a detailed performance study report.

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