Osteomed Alveolar Distraction System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K030790 ↗

FDA Product Code

MQN

Device Class

Class II

Regulation

21 CFR Part 872.4760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Osteomed LP →

• What types of dental procedures is the Osteomed Alveolar Distraction System primarily used for?

  The Osteomed Alveolar Distraction System is designed specifically for distraction osteogenesis in dental applications, particularly to gradually separate osteotomized bone segments in the mandible (lower jaw). This controlled bone growth process is used to address conditions requiring jaw expansion or reconstruction, such as congenital defects, trauma, or post-surgical bone loss.

• Is the Osteomed Alveolar Distraction System intended for single-use or can it be reused?

  The system is explicitly labeled as a reusable medical device, meaning it is engineered for multiple uses under sterile conditions. However, proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and functionality between procedures.

• How is the Osteomed Alveolar Distraction System supplied, and what components are included?

  The system is supplied as a reusable kit containing two bone plates, a threaded rod, and an activation instrument. These components work together to facilitate controlled bone separation during distraction osteogenesis procedures in the mandible.

• What regulatory pathway was followed for FDA clearance of this device, and when was it approved?

  The Osteomed Alveolar Distraction System received FDA 510(k) clearance through a Traditional review process, with a decision date of September 10, 2003. The clearance was based on a determination of substantial equivalence to a predicate device under FDA regulation number 872.4760.

• How should the Osteomed Alveolar Distraction System be stored to maintain its integrity?

  Since the system is reusable and intended for sterile use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper packaging and sterilization procedures must be followed before each use to ensure sterility and functionality.