# K161466: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Jan 24, 2017 after 242 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 K013468 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K053261: Orthofix Titanium Nailing Systems, Orthofix Srl (2005) Summary page 4.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 4.

## Most influential descendants
- K173458: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (2017), 0 descendants of its own

## Indications for use
The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization and fixation of various types of fractures or deformities. The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10 cm proximal to the intercondylar notch. These includes traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.

Source page: https://510kreport.com/device/K161466
Methodology: https://510kreport.com/methodology