# K040412: Trident T Acetabular Shells

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: May 25, 2004 after 97 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941141 (1994). 25 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010170: Trident Porous Titanium Acetabular Component, Howmedica Osteonics Corp. (2001) Summary page 1.
- K013475: Trident Porous Titanium Acetabular Component with Peri-Apatite Coating, Howmedica Osteonics Corp. (2001)
- K983502: Osteonics Secur-Fit AD Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 2.
- K983382: Osteonics HA Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 2.
- K013676: Trident Hemispherical Acetabular Shells, Howmedica Osteonics Corp. (2001) Summary page 2.

## 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

## Indications for use
The Trident® Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws. 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K040412
Methodology: https://510kreport.com/methodology