# K091425: Quantum M Composite Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: N.M.B. Medical Applications, Ltd.
- Decided: Jan 21, 2010 after 253 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: 8 generations back to K841189 (1984). 56 ancestors in all.
31 later devices descend from it; 7 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933518: Synthes Unreamed Humeral Nail (Urhn), Synthes (Usa) (1994) 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.
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 2.
- K052533: Kimba Spinal Implant, Signus Medizintechnik GmbH (2005) Summary page 2.
- K022615: Centerpulse, Spine-Tech Division Cement Restrictor, Centerpulse Spine-Tech, Inc. (2002) Summary page 2.
- K073649: Bengal Stackable Cage System, Depuy Spine, Inc. (2008) Summary page 2.
- K031401: Fixion Dynamic Hip Screw System (Fixion DHS), Disco-O-Tech Medical Technologies, Ltd. (2003) Summary page 2.

## Most influential descendants
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own
- 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

## Indications for use
Indications for the Quantum IM Composite Humeral 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 Quantum IM Composite Humeral Nail is indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.

Source page: https://510kreport.com/device/K091425
Methodology: https://510kreport.com/methodology