# K050655: Mondeal Radius HO System, Model KS-MR-2005

- Pathway: 510(k) (Traditional)
- Applicant: Kapp Surgical Instrument, Inc.
- Decided: Aug 8, 2005 after 147 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes (USA) Distal Radius Plate System (DRPS): named in the summary without a submission number
- (no number) Hand Innovations, Inc. Distal Radius Fracture Repair System: named in the summary without a submission number

## Most influential descendants
- K071798: Mondeal Distal Radius System (2007), 0 descendants of its own

## Indications for use
The Mondeal® RADIUS HO 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/K050655
Methodology: https://510kreport.com/methodology