# K140107: Emerge Medical Distal Radius Set

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical
- Decided: Mar 13, 2014 after 57 days
- Product code: HRS (Plate, Fixation, Bone)
- 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 K012114 (2001). 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)
- K091644: Synthes (Usa) 2.4MM LCP Volar Column Distal Radius Plates, Synthes (Usa) (2009) Summary page 2.
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 2.

## Indications for use
The Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones.

Source page: https://510kreport.com/device/K140107
Methodology: https://510kreport.com/methodology