# K171624: IXOS Radius Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Stuckenbrock Medizintechnik GmbH
- Decided: Mar 29, 2018 after 300 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: 5 generations back to K962616 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 5.
- K133246: Zimmer Distal Radius Plating System, Zimmer, Inc. (2013) Summary page 5.

## Indications for use
The IXOS Radius Plate System is intended for surgical procedures in which internal fixation by implants is required for aligning, reconstruction and stabilizing bone tissue. It is used in particular for fixing intra- and extra articular acute fractures of the distal radius, in particularly Type A2 Colles fractures Type A3 fractures Type B1 fractures Type B2 Barton fractures Type B3 Smith or reversed Barton fractures Type C1 fractures Type C2 fractures Type C3 fractures and in osteotomies of the distal radius.

Source page: https://510kreport.com/device/K171624
Methodology: https://510kreport.com/methodology