# K171768: Trident® II Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Decided: Oct 2, 2017 after 110 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921308 (1994). 43 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161569: Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2016) Summary page 4.
- K983382: Osteonics HA Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 4.
- K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach, Stryker Orthopaedics (2015) Summary page 4.
- K920868: Acetabular Dome and Screw Hole Plugs, Osteonics Corp. (1992) Summary page 4.

## Most influential descendants
- 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
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), 4 descendants of its own

## Recalls of this device
- Feb 27, 2024 · Class II · Z-1626-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1629-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1625-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1628-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1622-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1632-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1621-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1623-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1631-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1627-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1624-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Feb 27, 2024 · Class II · Z-1630-2024: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

## Indications for use
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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 Acetabular Shells are indicated for cementless use only.

Source page: https://510kreport.com/device/K171768
Methodology: https://510kreport.com/methodology