# K992515: Ebi Xfix DFS Optirom Elbow Fixator

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Aug 17, 1999 after 20 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EBI XFIX DFS Joint Fixator: named in the summary without a submission number

## Most influential descendants
- K020403: Modification to Ebi Xfix DFS Optirom Elbow Fixator (2002), 1 descendant of its own
- K021312: Ebi DFS Optirom Elbow Fixator (2002), 0 descendants of its own

## Indications for use
The EBI XFIX DFS® OptiROM™ Elbow Fixator external fixation device 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/K992515
Methodology: https://510kreport.com/methodology