# K021324: Fixion Intramedullary Nailing System (Fixion IM Nailing System)

- Pathway: 510(k) (Special)
- Applicant: Disco-O-Tech Medical Technologies, Ltd.
- Decided: May 23, 2002 after 27 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: 3 generations back to K970097 (1997). 18 ancestors in all.
54 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990717: Fixion Intramedullary Nailing System, Disco-O-Tech Medical Technologies, Ltd. (1999) Summary page 1.
- K003212: Fixion Intramedullary Nailing System (Fixion IM Nail), Disco-O-Tech Medical Technologies, Ltd. (2000) Summary page 1.
- K003215: Modification of Fixion Intramedullary Nailing System (Fixion IM Nail), Disco-O-Tech Medical Technologies, Ltd. (2000) Summary page 1.
- K010901: Fixion Intramedullary Nailing System (Fixion Imn) Model B, Disc-O-Tech Medical Technologies, Ltd. (2001) Summary page 1.
- K010988: Fixion Interlocking Proximal Femoral Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001) Summary page 1.
- K012967: Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System, Disco-O-Tech Medical Technologies, Ltd. (2001) Summary page 1.

## Most influential descendants
- K023437: Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail (2002), 53 descendants of its own
- K032588: Modification to Fixion Intramedullary Nailing System (Fixion IM) (2003), 32 descendants of its own
- K031401: Fixion Dynamic Hip Screw System (Fixion DHS) (2003), 32 descendants of its own
- K091425: Quantum M Composite Nailing System (2010), 31 descendants of its own
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own

## Recalls of this device
- Dec 11, 2002 · Not classified · Z-0943-03: The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.

## Indications for use
The Fixion Intramedullary Nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia and femur. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal.

Source page: https://510kreport.com/device/K021324
Methodology: https://510kreport.com/methodology