# K021911: Trident Crossfire Polyuethylene Liners

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 2, 2002 after 21 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
No predicates in its family tree.
54 later devices descend from it; 5 cite it directly.
0 of 55 devices 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) Osteonics Secur-Fit AD Generation II Acetabular Component System: named in the summary without a submission number
- (no number) Line Extension, Osteonics Trident Polyethylene Inserts: named in the summary without a submission number
- (no number) Line Extension, Trident Elevated Rim Liners: named in the summary without a submission number

## Most influential descendants
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners (2010), 23 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K122641: Mpact Extension (2012), 14 descendants of its own
- K132879: Mpact Extension (2014), 11 descendants of its own

## Indications for use
The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident series acetabular shells. (The predicate Trident series shells are intended for cementless fixation.) 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 failed 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/K021911
Methodology: https://510kreport.com/methodology