# K260115: DRIM-Nail System

- Pathway: 510(k) (Traditional)
- Applicant: 41Medical AG
- Decided: Sep 11, 2026 after 240 days
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K040938 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150073: MICRONAIL  Distal Radius System, Wrightmedicaltechnologyinc (2015) Summary page 5.

## Indications for use
The DRIM-Nail System is intended to be used for the fixation of unstable distal radius fractures of skeletally mature patients in which closed reduction is not suitable: • Failed fracture fixation with or without bone graft; • Osteotomy and repair of distal radius malunion with or without bone graft; • Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone

Source page: https://510kreport.com/device/K260115
Methodology: https://510kreport.com/methodology