# K001448: Trident Acetabular Shells: PS-HA

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 4, 2000 after 87 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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 K941141 (1994). 13 ancestors in all.
150 later devices descend from it; 4 cite it directly.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983382: Osteonics HA Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 1.
- K971854: Osteolock Acetabular Shell System, Howmedica Corp. (1997) Summary page 1.
- K933102: Howmedica Acetabular Shell W/Screw Holes, Howmedica Corp. (1994) Summary page 1.
- K993768: Citation TMZF HA Stem, Howmedica Osteonics Corp. (2000) Summary page 1.

## Most influential descendants
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own
- K071916: Metha Hip System (2008), 68 descendants of its own
- K013676: Trident Hemispherical Acetabular Shells (2001), 68 descendants of its own
- K082991: Biolox Delta Ceramic Femoral Head (2008), 63 descendants of its own

## Indications for use
The subject Trident Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts. Indications: 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. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K001448
Methodology: https://510kreport.com/methodology