# K102597: Piccolo Composite Plate System

- Pathway: 510(k) (Traditional)
- Applicant: N.M.B. Medical Applications, Ltd.
- Decided: Feb 24, 2011 after 167 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: 10 generations back to K841189 (1984). 87 ancestors in all.
15 later devices descend from it; 8 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 1.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 1.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 2.
- K002775: Distal Volar Radius Fracture Repair System, Hand Innovations, Inc. (2000) Summary page 2.
- K090374: Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10  2.5MM Threaded and Smooth Pegs, Model (S, DePuy Orthopaedics, Inc. (2009) Summary page 2.
- K091425: Quantum M Composite Nailing System, N.M.B. Medical Applications, Ltd. (2010) Summary page 2.
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System), N.M.B. Medical Applications, Ltd. (2010) Summary page 2.
- K031401: Fixion Dynamic Hip Screw System (Fixion DHS), Disco-O-Tech Medical Technologies, Ltd. (2003) Summary page 2.

## Most influential descendants
- K120409: Piccolo Composite Plate System (2012), 11 descendants of its own
- 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

## Indications for use
The Piccolo Composite Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients. The Piccolo Composite Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone. The Piccolo Composite Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.

Source page: https://510kreport.com/device/K102597
Methodology: https://510kreport.com/methodology