# K990717: Fixion Intramedullary Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Disco-O-Tech Medical Technologies, Ltd.
- Decided: Jun 2, 1999 after 90 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: 1 generation back to K803106 (1981). 10 ancestors in all.
56 later devices descend from it; 5 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K803106: Aginsky Nail, Cintor Orthopaedic Div. (1981) Summary page 2.
- K883882: Humeral Locking Nail System, Howmedica Corp. (1989) Summary page 2.
- K924004: Seidel Humeral Locking Nail -- Additional Lengths, Howmedica Corp. (1992) Summary page 2.
- K925544: Seidel Humeral Locking Nail & Additional Lengths, Howmedica Corp. (1993) Summary page 2.
- K931256: Seidel Humeral Locking Nail, Howmedica Corp. (1993) Summary page 2.
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 2.
- K914371: Universal Femoral Nail, Synthes (Usa) (1992) Summary page 2.
- K933518: Synthes Unreamed Humeral Nail (Urhn), Synthes (Usa) (1994) Summary page 2.
- K932330: TI-6AL-7NB Urtn, Synthes (Usa) (1996) Summary page 2.
- K923580: Synthes TI-6AI-7NB Unreamed Femoral Nail, Synthes (Usa) (1993) Summary page 2.

## Most influential descendants
- K021324: Fixion Intramedullary Nailing System (Fixion IM Nailing System) (2002), 54 descendants of its own
- K013449: Modification to Fixion Interlocking Intramedullary Nailing System (2001), 54 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K990717
Methodology: https://510kreport.com/methodology