# K012026: Trident All Poly Cup

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 18, 2001 after 20 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: 2 generations back to K001956 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001956: Trident All Poly Cup, Howmedica Osteonics Corp. (2000) Summary page 1.
- K010310: Modification to Trident All Poly Cup, Howmedica Osteonics Corp. (2001) Summary page 1.
- K010348: Tantalum Beads - Radiographic Marker, Biomet, Inc. (2001) Summary page 1.

## Indications for use
The Trident” All Poly Cup is a polyethylene acetabular component that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is designed to be cemented into the acetabulum. These acetabular cups are intended to be used with any Howmedica Osteonics’ femoral head.

Source page: https://510kreport.com/device/K012026
Methodology: https://510kreport.com/methodology