# K021312: Ebi DFS Optirom Elbow Fixator

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: May 23, 2002 after 28 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: 2 generations back to K981483 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
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.
- K020403: Modification to Ebi Xfix DFS Optirom Elbow Fixator, Ebi, L.P. (2002) Summary page 2.

## 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/K021312
Methodology: https://510kreport.com/methodology