# K014226: Unitrax Modular Unipolar System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 25, 2002 after 30 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902365 (1991). 1 ancestor in all.
18 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902365: Modular Unipolar System, Howmedica Corp. (1991) Summary page 1.

## Most influential descendants
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (2020), 6 descendants of its own

## Recalls of this device
- Jun 19, 2024 · Class II · Z-2372-2024: Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (4
- Jun 19, 2024 · Class II · Z-2371-2024: Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (4
- Jun 19, 2024 · Class II · Z-2370-2024: Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (4

## Indications for use
The Unitrax® Modular Unipolar System is intended to be used with a Howmedica Osteonics hip stem. When assembled to a hip stem, the resultant component functions in a similar fashion to a fixed head endoprosthesis. The endoprosthesis is used as a hemi-arthroplasty for the following indications: femoral neck fractures, idiopathic avascular necrosis and non-unions.

Source page: https://510kreport.com/device/K014226
Methodology: https://510kreport.com/methodology