# K013449: Modification to Fixion Interlocking Intramedullary Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Dec 19, 2001 after 63 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: 2 generations back to K803106 (1981). 17 ancestors in all.
54 later devices descend from it; 6 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002783: Fixion Interlocking Nail (Fixion IL Nail), Disco-O-Tech Medical Technologies, Ltd. (2000) Summary page 1.
- 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.
- K933518: Synthes Unreamed Humeral Nail (Urhn), Synthes (Usa) (1994) Summary page 1.
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 1.
- K923580: Synthes TI-6AI-7NB Unreamed Femoral Nail, Synthes (Usa) (1993) Summary page 1.
- K970733: Synthes Titanium Diastal Femoral Nail (TI DFN) System, Synthes (Usa) (1997) Summary page 1.
- K902264: True/Flex Humerus, Ulna and Radius Intramedullary, Applied Osteo Systems, Inc. (1990) 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

## Indications for use
The Fixion™ Interlocking Intramedullary Nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones.

Source page: https://510kreport.com/device/K013449
Methodology: https://510kreport.com/methodology