# K001449: Trident Acetabular Shells: PS

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 4, 2000 after 87 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- 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: 2 generations back to K903362 (1990). 11 ancestors in all.
69 later devices descend from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983502: Osteonics Secur-Fit AD 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)
- K972893: Partnership Revision  Femoral Stems, Howmedica Corp. (1997) Summary page 1.

## Most influential descendants
- K013676: Trident Hemispherical Acetabular Shells (2001), 68 descendants of its own
- K081171: Tritanium Acetabular Shell System (2008), 61 descendants of its own
- K040412: Trident T Acetabular Shells (2004), 23 descendants of its own
- K101072: Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite (2011), 22 descendants of its own
- K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach (2015), 21 descendants of its own

## Indications for use
The subject Trident Acetabular Shells are single-use devices intended for cemented or cementless fixation within the prepared acetabulurn. 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.oxher 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/K001449
Methodology: https://510kreport.com/methodology