# K161569: Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Decided: Oct 14, 2016 after 129 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: 6 generations back to K941141 (1994). 26 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081171: Tritanium Acetabular Shell System, Howmedica Osteonics Corp. (2008) Summary page 4.
- K943549: Restoration Acetabular Cup, Osteonics Corp. (1994) Summary page 4.

## Most influential descendants
- K171768: Trident® II Acetabular System (2017), 10 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own
- K191358: Trident II Acetabular System (2019), 6 descendants of its own
- K222632: UHR Bipolar Implants, Restoration GAP II Implants (2022), 5 descendants of its own
- K220376: Acetabular Dome Hole Plug (2022), 5 descendants of its own

## Indications for use
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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 is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. When used with MDM Liners • Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. • Dislocation risks When used with Constrained Liner: • The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. The Trident® II Tritanium® Acetabular Shells are indicated for cementless use only.

Source page: https://510kreport.com/device/K161569
Methodology: https://510kreport.com/methodology