# K151010: Piccolo Composite Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Jul 28, 2015 after 104 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: 14 generations back to K841189 (1984). 157 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K091425: Quantum M Composite Nailing System, N.M.B. Medical Applications, Ltd. (2010) Summary page 4.
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System), N.M.B. Medical Applications, Ltd. (2010) Summary page 4.
- K102369: Piccolo Composite Nailing System, N.M.B. Medical Applications, Ltd. (2011) Summary page 4.
- K111056: Piccolo Composite Nailing System, CarboFix Orthopedics, Ltd. (2011) Summary page 4.
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System, CarboFix Orthopedics, Ltd. (2013) Summary page 4.
- K132774: Piccolo Composite Nailing System, CarboFix Orthopedics, Ltd. (2013) Summary page 4.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 5.
- K011857: Synthes (Usa) Trochanteric Fixation Nail (TFN) System, Synthes (Usa) (2001) Summary page 5.
- K010988: Fixion Interlocking Proximal Femoral Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001) Summary page 5.
- K012967: Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System, Disco-O-Tech Medical Technologies, Ltd. (2001) Summary page 5.

## Most influential descendants
- K153536: Piccolo Composite® Nailing System (2016), 1 descendant of its own
- 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
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/K151010
Methodology: https://510kreport.com/methodology