# K081356: Olecranail Intramedullary Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Mylad Orthopedic Solutions, LLC
- Decided: Jul 9, 2008 after 56 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: 3 generations back to K913949 (1992). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073402: Synthes Olecranon Osteotomy Nailing System, Synthes (Usa) (2008) Summary page 1.
- K071944: Acumed Small Bone Locking System II, Acumed, LLC (2007) Summary page 1.
- K032548: IP-XS Compression Nail System, Plus Orthopedics (2003) Summary page 1.
- K920666: Intramedulary Fixation Rod, Acu Med, Inc. (1992) Summary page 1.

## Most influential descendants
- K090091: Olecranail Intramedullary Fixation System (2009), 1 descendant of its own
- K110322: Olecra Intramedullary Fixation System (2011), 0 descendants of its own

## Indications for use
The OlecraNailTM 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/K081356
Methodology: https://510kreport.com/methodology