# K032730: Fixion Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Mar 26, 2004 after 205 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 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.
- K030972: Fixion Unipolar Modular Hemi-Hip System (Fixion MH), Disc-O-Tech Medical Technologies, Ltd. (2003) Summary page 2.
- K994078: U1 Hip System, United Orthopedic Corp. (2000) Summary page 2.
- K871867: Elite Modular Hip System, Thackray USA (1988) Summary page 2.
- K851422: S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip, Joint Medical Products Corp. (1985) Summary page 2.
- K913231: S-Rom (TM) Total Lhip System W/Ceramic Head, Joint Medical Products Corp. (1991) Summary page 2.
- K954935: S-Rom Femoral Hip Stem - Size 14 X 8, Joint Medical Products Corp. (1996) Summary page 2.
- K961939: S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115), Johnson & Johnson Professionals, Inc. (1996) Summary page 2.
- K955296: Link MP Reconstruction Hip, Link America, Inc. (1996) 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.
- 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.

## Indications for use
The Fixion® Hip System is intended for use as a hemi-hip or total hip replacement. The Fixion® Hip System is indicated as a unipolar hemi-hip replacement 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 involvement. The Fixion® Hip System is indicated as a total hip replacement in cases of: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. The Fixion® Hip Stem is intended for cemented or non-cemented use.

Source page: https://510kreport.com/device/K032730
Methodology: https://510kreport.com/methodology