# K012967: Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System

- Pathway: 510(k) (Special)
- Applicant: Disco-O-Tech Medical Technologies, Ltd.
- Decided: Oct 4, 2001 after 30 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: 2 generations back to K970097 (1997). 3 ancestors in all.
56 later devices descend from it; 9 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010988: Fixion Interlocking Proximal Femoral Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001) Summary page 1.

## Most influential descendants
- K021324: Fixion Intramedullary Nailing System (Fixion IM Nailing System) (2002), 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
- K091425: Quantum M Composite Nailing System (2010), 31 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 Interlocking Proximal Femoral Nailing System (“Fixion PF”) is intended for use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. The long Fixion PF may also be used in mid shaft fractures, 5cm below the surgical neck to Scm proximal to the distal end of the medullar canal. The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, revision procedures.

Source page: https://510kreport.com/device/K012967
Methodology: https://510kreport.com/methodology