# K130061: Piccolo Composite Plate System

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Feb 27, 2013 after 48 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K841189 (1984). 126 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102597: Piccolo Composite Plate System, N.M.B. Medical Applications, Ltd. (2011) Summary page 2.
- K120409: Piccolo Composite Plate System, CarboFix Orthopedics, Ltd. (2012) Summary page 2.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 2.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 2.

## Most influential descendants
- K160002: Piccolo Composite (R) Distal Volar Radius Plate System (2016), 4 descendants of its own
- K143496: Piccolo Composite Plate System (2015), 4 descendants of its own
- K170401: Piccolo Composite® Plate System (2017), 3 descendants of its own
- K132774: Piccolo Composite Nailing System (2013), 3 descendants of its own
- K151010: Piccolo Composite Nailing System (2015), 2 descendants of its own

## Indications for use
Piccolo Composite Plate System - Diaphyseal The Piccolo Composite Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.

Source page: https://510kreport.com/device/K130061
Methodology: https://510kreport.com/methodology