# K100497: Quantum IM Composite Nailing System (Quantum Nailing System)

- Pathway: 510(k) (Special)
- Applicant: N.M.B. Medical Applications, Ltd.
- Decided: Jun 21, 2010 after 119 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: 9 generations back to K841189 (1984). 63 ancestors in all.
29 later devices descend from it; 5 cite it directly.
0 of 93 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.
- K032722: Trigen Straight Humeral Nail System, Smith & Nephew, Inc. (2003) Summary page 2.
- K032523: T2 Nailing System, Howmedica Osteonics Corp. (2003) Summary page 2.
- K042396: T2 Proximal Humeral Nail, Howmedica Osteonics Corp. (2004) Summary page 2.
- K043404: Modification to T2 Proximal Humeral Nail, Howmedica Osteonics Corp. (2004) Summary page 2.

## Most influential descendants
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own
- K102597: Piccolo Composite Plate System (2011), 15 descendants of its own
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System (2013), 14 descendants of its own
- K120409: Piccolo Composite Plate System (2012), 11 descendants of its own

## Indications for use
Piccolo Composite Humeral and Proximal Humerus Nails Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral 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 Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.

Source page: https://510kreport.com/device/K100497
Methodology: https://510kreport.com/methodology