# K071798: Mondeal Distal Radius System

- Pathway: 510(k) (Traditional)
- Applicant: Mondeal Medical Systems GmbH
- Decided: Sep 17, 2007 after 77 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 K050655 (2005). 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)
- K050655: Mondeal Radius HO System, Model KS-MR-2005, Kapp Surgical Instrument, Inc. (2005) Summary page 1.

## Indications for use
The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Source page: https://510kreport.com/device/K071798
Methodology: https://510kreport.com/methodology