# K173652: Piccolo Composite Nailing System

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Dec 28, 2017 after 30 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: 16 generations back to K841189 (1984). 159 ancestors in all.
No later device cites it as a predicate yet.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153536: Piccolo Composite® Nailing System, CarboFix Orthopedics, Ltd. (2016) Summary page 5.
- K151010: Piccolo Composite Nailing System, CarboFix Orthopedics, Ltd. (2015) Summary page 5.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 5.

## Indications for use
The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, malunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

Source page: https://510kreport.com/device/K173652
Methodology: https://510kreport.com/methodology