# K014072: Fixion Unipolar Modular Hemi-Hip System (Fixion UH)

- Pathway: 510(k) (Traditional)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Mar 8, 2002 after 88 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
65 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Depuy Orthopeadics' Elite® Modular Hip System: named in the summary without a submission number
- (no number) Depuy Orthopeadics' S-ROM Total Hip System: named in the summary without a submission number
- (no number) Disc-O-Tech's Fixion™ Interlocking PF Intramedullary Nailing System: named in the summary without a submission number
- (no number) Link America, Inc.'s Link® Reconstruction Hip: named in the summary without a submission number
- (no number) Smith and Nephew’s Biolox® Alumina Ceramic Femoral Head: named in the summary without a submission number

## Most influential descendants
- 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
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own

## Indications for use
The Fixion Unipolar Modular Hemi-Hip System is intended for cemented or non-cemented use as a hemi hip replacement in cases of: Femoral head/neck fractures or non-unions Aseptic necrosis of the femoral head/neck Osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement

Source page: https://510kreport.com/device/K014072
Methodology: https://510kreport.com/methodology