# K030605: Rapid Imf

- Pathway: 510(k) (Traditional)
- Applicant: Zygomatics, Ltd.
- Decided: Jun 27, 2003 after 122 days
- Product code: DYX (Lock, Wire, And Ligature, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.4600
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162046: MINNE TIES MMF Suture System (2017), 0 descendants of its own

## Indications for use
The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band). Rapid IMF is suitable for: = Pre-operative fixation = Per-operative fixation Short-temi (up to 3 weeks) fixation for minimally displaced fractures Splintage post jaw dislocation

Source page: https://510kreport.com/device/K030605
Methodology: https://510kreport.com/methodology