# K102369: Piccolo Composite Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: N.M.B. Medical Applications, Ltd.
- Decided: Jan 31, 2011 after 164 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: 10 generations back to K841189 (1984). 74 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 91 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.
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 1.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 1.
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 1.
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001) Summary page 2.
- 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.
- K923580: Synthes TI-6AI-7NB Unreamed Femoral Nail, Synthes (Usa) (1993) Summary page 2.
- K954856: Cannulated Femoral Nail, Synthes (Usa) (1996) 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.

## Most influential descendants
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own
- 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

## 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/K102369
Methodology: https://510kreport.com/methodology