# K022799: Trident Screw Hole Plug and Trident Bone Spike

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 21, 2002 after 90 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 no predicate by number.

## Most influential descendants
- K130353: Pipeline Total Hip System (Line Extension) (2013), 1 descendant of its own
- K132626: Pipeline Total Hip System (Line Extension) (2013), 0 descendants of its own

## Indications for use
The Trident® Screw Hole Plugs are optional single-use devices that are intended to occlude the unused screw holes of the Trident® Porous Titanium Acetabular Component or the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating. The Trident® Screw Hole Plugs will be used either with or without bone cement depending upon the surgical application of the Trident® shell. More specifically, these Trident® Screw Holes Plugs have the following indications and contraindications: Indications In cemented or cementless hip arthroplasty, when a screw hole plug is thought to be advantageous Contraindications Obesity. An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device itself. The Trident® Bone Spikes are optional single-use devices that are intended to provide supplemental fixation of the Trident® Porous Titanium Acetabular Shell or the Trident® Porous Titanium Acetabular Shell with Peri-Apatite™ Coating in the prepared acetabulum in total hip arthroplasty. These Trident® Bone Spikes are intended to be used when the above-referenced Trident® acetabular shells are used in a press fit application. More specifically, these Trident® Bone Spikes have the following indications and contraindications: Trident® Bone Spikes are intended for supplemental fixation of the Trident® Porous Titanium Acetabular Shell and the Trident® Porous Titanium Acetabular Shell with Peri-Apatite Coating only. Trident® Bone Spikes should be assembled to the Trident® acetabular shell prior to placement of the shell into the prepared acetabulum.

Source page: https://510kreport.com/device/K022799
Methodology: https://510kreport.com/methodology