# K132774: Piccolo Composite Nailing System

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Oct 3, 2013 after 28 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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). 151 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K102369: Piccolo Composite Nailing System, N.M.B. Medical Applications, Ltd. (2011) Summary page 2.
- K111056: Piccolo Composite Nailing System, CarboFix Orthopedics, Ltd. (2011)
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System, CarboFix Orthopedics, Ltd. (2013) Summary page 2.
- K130061: Piccolo Composite Plate System, CarboFix Orthopedics, Ltd. (2013) Summary page 2.

## Most influential descendants
- K151010: Piccolo Composite Nailing System (2015), 2 descendants of its own
- K153536: Piccolo Composite® Nailing System (2016), 1 descendant of its own
- K173652: Piccolo Composite Nailing System (2017), 0 descendants of its own

## Indications for use
Piccolo Composite Humeral. Proximal Humerus. Tibial and Femoral Nails Indications include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. Piccolo Composite Ankle Arthrodesis Nails Indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: Avascular necrosis of the talus; Failed total ankle arthroplasty; Trauma (malunited tibial pilon fracture); Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease; Revision ankle arthrodesis; Neuroarthropathy; Rheumatoid arthritis; Osteoarthritis; Pseudoarthrosis; Post-traumatic artbrosis; Previously infected arthrosis; Charcot foot; Severe endstage degenerative arthritis; Severe defects after tumor resection; Pantalar arthrodesis

Source page: https://510kreport.com/device/K132774
Methodology: https://510kreport.com/methodology