# K030790: Osteomed Alveolar Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Sep 10, 2003 after 182 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K792561 (1979). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002152: Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction, KLS-Martin L.P. (2000)
- K973484: Chin Distractor, Howmedica, Inc. (1997) Summary page 1.
- K992952: Lorenz Distraction System, Walter Lorenz Surgical, Inc. (1999) Summary page 1.

## Indications for use
Intended for use in patients who have totally or partially edentulous mandible or maxilla or small craniofacial bone deficiencies and need an increase in bone height and mass by means of distraction osteogenesis. These patients include those who have traumatic defects, periodontal disease or birth abnormality. The distractor is designed to provide temporary stabilization and gradual expansion across an osteotomy in the mandibular bone or maxillary bone and thereby increasing the height of the adjacent Alveolar ridge. This device is intended to be removed after consolidation of the callus and prior to final prosthetic reconstruction. The OsteoMed Alveolar Distraction System is intended for single patient use only.

Source page: https://510kreport.com/device/K030790
Methodology: https://510kreport.com/methodology