# K252312: Eleganz IM Threaded Nail System (IM Threaded Nail System)

- Pathway: 510(k) (Traditional)
- Applicant: Dev4
- Decided: Oct 10, 2025 after 78 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: 7 generations back to K962823 (1996). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120493: Mini Cannulated Headed and Headless Screw Set, Instratek, Inc. (2012)
- K183603: INnate Cannulated Screw System, Exsomed Corporation (2019) Summary page 5.

## Cited in the summary but kept off the family tree
- K230474: EVA5 Insufflator, Palliare, Ltd. (2023). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Eleganz™ IM Threaded Nail 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 nails are not intended for interference or soft tissue fixation.

Source page: https://510kreport.com/device/K252312
Methodology: https://510kreport.com/methodology