# K162898: Olecranon Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Miami Device Solutions, LLC
- Decided: Mar 17, 2017 after 151 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: 11 generations back to K962616 (1996). 99 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143394: Acumed Small Fragment Base Set, Acumed, LLC (2015) Summary page 4.
- K161292: Distal Radius Plating System, Miami Device Solutions, LLC (2016) Summary page 4.
- K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 4.

## Most influential descendants
- K172786: MDS Plating System (2017), 0 descendants of its own

## Indications for use
The MDS Olecranon Plating System is intended for internal fixation of fractures of the Olecranon.

Source page: https://510kreport.com/device/K162898
Methodology: https://510kreport.com/methodology