# K033716: Trident Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 10, 2005 after 442 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
64 later devices descend from it; 5 cite it directly.
0 of 65 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) Trident® Hip System: named in the summary without a submission number

## Most influential descendants
- K061434: Trident Large Diameter Hip System (2006), 54 descendants of its own
- K110290: Exeter Hip Stem (2011), 37 descendants of its own
- K062419: Trident Large Diameter Acetabular Inserts (2006), 23 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners (2010), 16 descendants of its own

## Recalls of this device
- Jun 25, 2015 · Class II · Z-2810-2015: it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently ship
- Feb 17, 2006 · Not classified · Z-0909-2010: Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.

## Indications for use
The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident® Acetabular Shells. The Trident® Acetabular Shells are intended for cementless fixation. The Trident® Acetabular Hip System Polyethylene inserts are indicated for use in total hip arthroplasty in the following instances: Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis. Revision of previous failed femnoral 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/K033716
Methodology: https://510kreport.com/methodology