# K182015: Piccolo Composite® Plate System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Oct 11, 2018 after 76 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: 15 generations back to K841189 (1984). 204 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 206 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 5.
- K120409: Piccolo Composite Plate System, CarboFix Orthopedics, Ltd. (2012) Summary page 5.
- K130061: Piccolo Composite Plate System, CarboFix Orthopedics, Ltd. (2013) Summary page 5.
- K143496: Piccolo Composite Plate System, CarboFix Orthopedics, Ltd. (2015) Summary page 5.
- K160002: Piccolo Composite (R) Distal Volar Radius Plate System, CarboFix Orthopedics, Ltd. (2016) Summary page 5.
- K170401: Piccolo Composite® Plate System, CarboFix Orthopedics, Ltd. (2017) Summary page 5.
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System, Wrightmedicaltechnologyinc (2015) Summary page 5.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 5.

## Most influential descendants
- K201917: Piccolo Composite Proximal Tibia Plate System (2020), 0 descendants of its own

## Indications for use
Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bones and small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and including in osteopenic bone. The Lapidus plates are indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions).

Source page: https://510kreport.com/device/K182015
Methodology: https://510kreport.com/methodology