# K063616: Trident II Acetabular System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 20, 2006 after 15 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Trident® Acetabular System: named in the summary without a submission number

## Indications for use
The subject Trident ® II Acetabular Shells are intended for cementless fixation within the prepared acetabulum. The subject Acetabular shells intended for use with mating Trident® II X3® Polyethylene Inserts. 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 isof poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K063616
Methodology: https://510kreport.com/methodology