# K020403: Modification to Ebi Xfix DFS Optirom Elbow Fixator

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Mar 8, 2002 after 29 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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
Longest line of descent: 1 generation back to K981483 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992515: Ebi Xfix DFS Optirom Elbow Fixator, Ebi, L.P. (1999) Summary page 1.
- K981483: Ebi DFS Joint Fixator, Model 02800, Electro-Biology, Inc. (1998) Summary page 1.

## Most influential descendants
- K021312: Ebi DFS Optirom Elbow Fixator (2002), 0 descendants of its own

## Indications for use
The EBI® XFIX® DFS® OptiROM® Elbow Fixator is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include: 1. Fracture dislocation with ligamentos instability. 2. Comminuted intra-articular fractures. 3. Post traumatic reconstruction for joint stiffness.

Source page: https://510kreport.com/device/K020403
Methodology: https://510kreport.com/methodology