# K143496: Piccolo Composite Plate System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: May 29, 2015 after 171 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). 133 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 138 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.
- K060969: Polyax Locked Plating System, DePuy Orthopaedics, Inc. (2006) Summary page 5.
- K083025: Synthes 4.5 MM VA-LCP Curved Condylar System, Synthes (Usa) (2009) Summary page 5.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) 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 Femur Plate System is indicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

Source page: https://510kreport.com/device/K143496
Methodology: https://510kreport.com/methodology