# K170401: Piccolo Composite® Plate System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: May 12, 2017 after 92 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: 14 generations back to K841189 (1984). 169 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 173 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.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 5.
- K101962: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2010) Summary page 5.
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology, Orthohelix Surgical Designs, Inc. (2010) Summary page 5.

## Most influential descendants
- K182015: Piccolo Composite® Plate System (2018), 1 descendant of its own
- K213698: CoLink PCR Plating System (2022), 0 descendants of its own
- K201917: Piccolo Composite Proximal Tibia Plate System (2020), 0 descendants of its own

## Indications for use
The 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 MTP plates are indicated for treatment of deformations, fractures, nonunions and replantations of the 1st metatarso-phalangeal joint and 1st metatarsal bone.

Source page: https://510kreport.com/device/K170401
Methodology: https://510kreport.com/methodology