# K120409: Piccolo Composite Plate System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Nov 26, 2012 after 291 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: 11 generations back to K841189 (1984). 125 ancestors in all.
11 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.
- K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 2.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001)
- K081284: Variax Distal Fibula Plate, Howmedica Osteonics Corp. (2008) Summary page 2.
- K000636: Stryker Trauma Plating System, Howmedica Osteonics Corp. (2000) Summary page 2.
- K111041: Mini Variable System, Orthohelix Surgical Designs, Inc. (2011)

## Most influential descendants
- K130061: Piccolo Composite Plate System (2013), 10 descendants of its own
- 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

## Indications for use
Piccolo Composite Distal Fibula Plate System The Piccolo Composite Distal Fibula Plates are indicated for fractures, osteotomnies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone. Piccolo Composite One-Third Tubular Plate System The Piccolo Composite One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone. Piccolo Composite Proximal Humerus Plate System The Piccolo Composite Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone. Piccolo Composite Distal Volar Radius Plate System The Piccolo Composite Distal Volar Radius Plate is indicated for fractures and osteotomnies of the distal volar radius.

Source page: https://510kreport.com/device/K120409
Methodology: https://510kreport.com/methodology