# K071679: Metafix and Fixion FA Intramedullary Nailing Systems

- Pathway: 510(k) (Traditional)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Dec 17, 2007 after 181 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: 5 generations back to K970097 (1997). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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 2.
- K010901: Fixion Intramedullary Nailing System (Fixion Imn) Model B, Disc-O-Tech Medical Technologies, Ltd. (2001) Summary page 2.
- K010988: Fixion Interlocking Proximal Femoral Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001)
- K012967: Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System, Disco-O-Tech Medical Technologies, Ltd. (2001) Summary page 2.
- K023437: Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail, Disco-O-Tech Medical Technologies, Ltd. (2002) Summary page 2.
- K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension), Synthes (Usa) (2004) Summary page 2.
- K902264: True/Flex Humerus, Ulna and Radius Intramedullary, Applied Osteo Systems, Inc. (1990) Summary page 2.
- K913949: True/Flex Humerus, Ulna & Radius Intramed Rods Sys, Applied Osteo Systems, Inc. (1992) Summary page 2.

## Indications for use
The MetaFix Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones. The Fixion FA Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.

Source page: https://510kreport.com/device/K071679
Methodology: https://510kreport.com/methodology