# K022230: Normed Mini External Fixator System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomedics, Inc.
- Decided: Sep 10, 2002 after 62 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Normed Mini External Fixator System can be used as a static fixator or dynamically applying distraction or compression to the small bones of fmger and toe. The system provides treatment for small bone fiactures, including severe open finger and toe fractures, highly comminuted close fractures, monunion and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, figure and toe deformity corrections, bum maintenance, and bone-grafting defects and hsion of a joint. The system can be used in both adult and pediatric patients.

Source page: https://510kreport.com/device/K022230
Methodology: https://510kreport.com/methodology