# K032588: Modification to Fixion Intramedullary Nailing System (Fixion IM)

- Pathway: 510(k) (Special)
- Applicant: Disco-O-Tech Medical Technologies, Ltd.
- Decided: Sep 12, 2003 after 21 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). 24 ancestors in all.
32 later devices descend from it; 3 cite it directly.
0 of 57 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)
- K003215: Modification of Fixion Intramedullary Nailing System (Fixion IM Nail), Disco-O-Tech Medical Technologies, Ltd. (2000)
- K010901: Fixion Intramedullary Nailing System (Fixion Imn) Model B, Disc-O-Tech Medical Technologies, Ltd. (2001)
- K021324: Fixion Intramedullary Nailing System (Fixion IM Nailing System), Disco-O-Tech Medical Technologies, Ltd. (2002)
- K023437: Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail, Disco-O-Tech Medical Technologies, Ltd. (2002) Summary page 1.
- K002783: Fixion Interlocking Nail (Fixion IL Nail), Disco-O-Tech Medical Technologies, Ltd. (2000) Summary page 1.
- K013449: Modification to Fixion Interlocking Intramedullary Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001)
- 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)
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 2.
- K914371: Universal Femoral Nail, Synthes (Usa) (1992) Summary page 2.

## Most influential descendants
- 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
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own
- K102597: Piccolo Composite Plate System (2011), 15 descendants of its own

## Indications for use
These devices are indicated for the following: Femur: - fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; - proximal femoral fi-actures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these kactures; - use in osteotomy, rionunions and malunions, bone reconstruction following tumor resection, grafting arid pathological fractures, and revision procedures in the femur; - mid shaft fractures -1 the femur ( 5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal); - comminuted shaft fractures; - fixation of short distal or proximal fragments Tibia: - diaphyseal shaft fractures in the tibia; - comminuted shaft fi-actures; - fixation of short distill or proximal fragments Humerus: - diaphyseal shaft fractures in the humerus; - comminuted shaft hctures; - fixation of short distal or proximal fragments

Source page: https://510kreport.com/device/K032588
Methodology: https://510kreport.com/methodology