# K090091: Olecranail Intramedullary Fixation System

- Pathway: 510(k) (Special)
- Applicant: Mylad Orthopedic Solutions, LLC
- Decided: Feb 1, 2009 after 18 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951740 (1995). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081356: Olecranail Intramedullary Fixation System, Mylad Orthopedic Solutions, LLC (2008) Summary page 1.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 1.
- K002775: Distal Volar Radius Fracture Repair System, Hand Innovations, Inc. (2000) Summary page 1.

## Most influential descendants
- K110322: Olecra Intramedullary Fixation System (2011), 0 descendants of its own

## Indications for use
The OlecraNail'M Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.

Source page: https://510kreport.com/device/K090091
Methodology: https://510kreport.com/methodology