(89 days)
The Synthes MLA is intended for use as a stabilizer and lengthener to be used in craniofacial-maxillofacial and mandibular deficiencies or post-traumatic defects, where gradual bone distraction is required.
Synthes MLA is a telescoping tube mechanism, consisting of two tubes with pin clamps on the end of each tube. The tube mechanism expands and contracts by turning an outer wheel (clockwise to contract and counterclockwise to expand). The wheel is secured in place by a jack screw which has an axially retained threaded shaft with a round end. The pin clamps secure 2.0 - 2.5 mm K-wires to the tubes. The MLA is available in two sizes: One has lengths ranging from 75 mm to 110 mm; the other has lengths ranging from 100 mm to 160 mm.
The provided document is a 510(k) summary for the Synthes Mini Lengthening Apparatus (MLA). This document does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Howmedica's Hoffmann Mini Lengthening Apparatus, K792561) for market clearance, rather than presenting a performance study with defined acceptance criteria.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, or details about a comparative effectiveness study.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.