# K021749: Ebi Dynafix VS Osteotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Aug 12, 2002 after 76 days
- Product code: NDF (Plate, Fixation, Bone, Non-Spinal, Metallic)
- 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 K010551 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010551: Ebi Dynafix VS Osteotomy System, Ebi, L.P. (2001)

## Indications for use
The EBI DynaFix VST Osteotomy System is intended for fixation following acute corrective opening wedge osteotomies in long bone.

Source page: https://510kreport.com/device/K021749
Methodology: https://510kreport.com/methodology