# K153536: Piccolo Composite® Nailing System

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Jan 6, 2016 after 27 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K841189 (1984). 158 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151010: Piccolo Composite Nailing System, CarboFix Orthopedics, Ltd. (2015) Summary page 5.
- K102369: Piccolo Composite Nailing System, N.M.B. Medical Applications, Ltd. (2011) Summary page 5.
- K111056: Piccolo Composite Nailing System, CarboFix Orthopedics, Ltd. (2011) Summary page 5.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 5.

## Most influential descendants
- K173652: Piccolo Composite Nailing System (2017), 0 descendants of its own

## Recalls of this device
- May 10, 2016 · Class II · Z-1991-2016: Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

## Indications for use
Piccolo Composite Proximal Femur Nails 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/K153536
Methodology: https://510kreport.com/methodology