# K053261: Orthofix Titanium Nailing Systems

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Dec 12, 2005 after 20 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K121312: Intramedullary Nail System (2012), 3 descendants of its own
- K161466: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (2017), 1 descendant of its own
- K132078: Metallic Intramedullary Nail System (2014), 1 descendant of its own
- K173458: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (2017), 0 descendants of its own
- K151062: WASTON Metallic Intramedullary Nail System (2015), 0 descendants of its own

## Indications for use
Each nail within the Orthofix Titanium Nailing System is intended for insertion into the medullary canal of a specific long bone - humerus, femur and tibia - for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.

Source page: https://510kreport.com/device/K053261
Methodology: https://510kreport.com/methodology