# K142606: Trident® Tritanium® PST® Acetabular Shells

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Jan 26, 2015 after 133 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: 8 generations back to K931641 (1994). 90 ancestors in all.
No later device cites it as a predicate yet.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112802: Pipeline Total Hip System, Pipeline Orthopedics (2012) Summary page 4.
- K081171: Tritanium Acetabular Shell System, Howmedica Osteonics Corp. (2008) Summary page 4.
- K983382: Osteonics HA Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 4.
- K013676: Trident Hemispherical Acetabular Shells, Howmedica Osteonics Corp. (2001) Summary page 4.

## Indications for use
The Trident® Tritanium® PST® Acetabular Shell System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: • A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia; • Acute traumatic fracture of the femoral head or neck; • Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement. The Trident® Tritanium® PST® Acetabular Shell is intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

Source page: https://510kreport.com/device/K142606
Methodology: https://510kreport.com/methodology