# K050478: Medicon Imf-Orion Screws

- Pathway: 510(k) (Traditional)
- Applicant: Medicon EG
- Decided: Jun 15, 2005 after 111 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K820944 (1982). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010527: Synthes (Usa) Imf Screws, Synthes (Usa) (2001) Summary page 1.
- K983728: Lorenz Imf Screw, Walter Lorenz Surgical, Inc. (1999) Summary page 1.
- K980760: KLS-Martin MMF Screw, KLS-Martin L.P. (1999) Summary page 1.
- K963030: Leibinger Imf Screw, Howmedica Leibinger, Inc. (1997) Summary page 1.

## Indications for use
The Medicon IMF Orion Screws are intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla, martdible or both.

Source page: https://510kreport.com/device/K050478
Methodology: https://510kreport.com/methodology