# K071797: Mondeal Hand Contour 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 K961497 (1996). 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)
- K961497: Profyle Titanium Hand and Small Fragment System, Howmedica, Inc. (1996) Summary page 1.

## Indications for use
The Mondeal® HAND CONTOUR System is intended to be used for the internal fixation of small bones including the hand and the foot.

Source page: https://510kreport.com/device/K071797
Methodology: https://510kreport.com/methodology