# K030972: Fixion Unipolar Modular Hemi-Hip System (Fixion MH)

- Pathway: 510(k) (Special)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: May 30, 2003 after 63 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970097 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014072: Fixion Unipolar Modular Hemi-Hip System (Fixion UH), Disc-O-Tech Medical Technologies, Ltd. (2002) Summary page 2.
- K010988: Fixion Interlocking Proximal Femoral Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001) Summary page 2.
- K012967: Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System, Disco-O-Tech Medical Technologies, Ltd. (2001) Summary page 2.

## Most influential descendants
- K032730: Fixion Hip System (2004), 0 descendants of its own

## Indications for use
The Fixion@ MH System intended for cemented or non-cemented use as a hemi-hip replacement. It is indicated for use in cases of: Femoral head and/or neck fractures or non-unions; Aseptic necrosis of the femoral head and/or neck; Osteo-, Rheumatoid-, and/or Post-traumatic arthritis of the hip, with minimal acetabular iiivolvement.

Source page: https://510kreport.com/device/K030972
Methodology: https://510kreport.com/methodology