# K250251: Eleganz Fusion Screw System (Fusion Screw System)

- Pathway: 510(k) (Traditional)
- Applicant: Dev4
- Decided: Jun 13, 2025 after 136 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K000684 (2000). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230744: Acumed Acutrak 3 Headless Compression Screw System, Acumed, LLC (2023) Summary page 5.
- K190324: OrthoPediatrics Cannulated Screw System, OrthoPediatrics Corp. (2019) Summary page 5.
- K131620: Jones-FX Fracture System, Instratek, Inc. (2013) Summary page 5.

## Indications for use
The Eleganz™ Fusion Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies. The screws are not intended for interference or soft tissue fixation.

Source page: https://510kreport.com/device/K250251
Methodology: https://510kreport.com/methodology