# K110322: Olecra Intramedullary Fixation System

- Pathway: 510(k) (Special)
- Applicant: Mylad Orthopedic Solutions
- Decided: Mar 4, 2011 after 29 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: 5 generations back to K951740 (1995). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063460: Acumed Congruent Bone Plate System, Acumed, LLC (2006) Summary page 1.
- K090091: Olecranail Intramedullary Fixation System, Mylad Orthopedic Solutions, LLC (2009) Summary page 1.
- (no number) Acumed ulna shortening osteotomy guide: named in the summary without a submission number
- (no number) Biomet Premier Total Knee Instrumentation: named in the summary without a submission number

## Indications for use
The OlecraNail® 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/K110322
Methodology: https://510kreport.com/methodology