# K111056: Piccolo Composite Nailing System

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: May 3, 2011 after 15 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 78 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 94 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 1.
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System), N.M.B. Medical Applications, Ltd. (2010) Summary page 1.
- K102369: Piccolo Composite Nailing System, N.M.B. Medical Applications, Ltd. (2011) Summary page 1.
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 1.
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001)
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 2.
- K962047: Titanium Cannulated Tibial Nail (TI CTN), Synthes (Usa) (1996) Summary page 2.
- K033618: Synthes (Usa) Retrograde/Antegrade Femoral Nail System, Synthes (Usa) (2004) Summary page 2.
- K002783: Fixion Interlocking Nail (Fixion IL Nail), Disco-O-Tech Medical Technologies, Ltd. (2000) Summary page 2.
- K013449: Modification to Fixion Interlocking Intramedullary Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001) Summary page 2.
- K032588: Modification to Fixion Intramedullary Nailing System (Fixion IM), Disco-O-Tech Medical Technologies, Ltd. (2003) Summary page 2.
- K965098: Intramedullary Nail System, Zimmer, Inc. (1997) Summary page 2.

## Most influential descendants
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System (2013), 14 descendants of its own
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own
- K192163: TTC Phantom® Intramedullary Nail System (2020), 6 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own
- K201227: Phantom® Hindfoot TTC/TC Nail System (2020), 5 descendants of its own

## Recalls of this device
- May 10, 2016 · Class II · Z-1991-2016: Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

## Indications for use
Indications for the Piccolo Composite Tibial and Femoral Nails 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 Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

Source page: https://510kreport.com/device/K111056
Methodology: https://510kreport.com/methodology