# K160002: Piccolo Composite (R) Distal Volar Radius Plate System

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Mar 9, 2016 after 65 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: 13 generations back to K841189 (1984). 128 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 133 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 4.
- K120409: Piccolo Composite Plate System, CarboFix Orthopedics, Ltd. (2012) Summary page 4.
- K130061: Piccolo Composite Plate System, CarboFix Orthopedics, Ltd. (2013) Summary page 4.
- K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates, Synthes (Usa) (2009) Summary page 5.

## Most influential descendants
- K170401: Piccolo Composite® Plate System (2017), 3 descendants of its own
- 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 Distal Volar Radius Plate System is indicated for fractures and osteotomies of the distal volar radius.

Source page: https://510kreport.com/device/K160002
Methodology: https://510kreport.com/methodology