# K030485: Newmedical Micro Bone Distractor/Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Newmedical Technology, Inc.
- Decided: Dec 3, 2003 after 292 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hoffman Mini Fixator: named in the summary without a submission number
- (no number) Synthes Mini-Lengthener: named in the summary without a submission number
- (no number) Mandibular Bone Lengthener: named in the summary without a submission number

## Most influential descendants
- K040064: Newmedical Micro Bone Distractor/Fixator (2004), 0 descendants of its own

## Indications for use
For pediatric patients, for external fixation of mandibular fractures or for mandibular distraction.

Source page: https://510kreport.com/device/K030485
Methodology: https://510kreport.com/methodology