# K180130: ELEOS™ Bipolar Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Onkos Surgical, Inc.
- Decided: Feb 23, 2018 after 37 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- 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 K062693 (2006). 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)
- K062693: Gladiator Bipolar System, Wrightmedicaltechnologyinc (2006) Summary page 4.

## Indications for use
The ELEOS™ Bipolar Acetabular System is indicated for the following conditions: 1) pathological fractures of the femoral neck 2) non-union of femoral neck fractures 3) aseptic necrosis of the femoral head and neck 4) primary pathology involving the femoral head or femur but with a non-deformed acetabulum.

Source page: https://510kreport.com/device/K180130
Methodology: https://510kreport.com/methodology