# K232556: DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System

- Pathway: 510(k) (Special)
- Applicant: Depuy Ireland UC
- Decided: Sep 20, 2023 after 28 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 K930712 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201348: DePuy 3D Additive TriFlange Acetabular Cup, Depuy International, Ltd. (2022) Summary page 5.
- K040383: Triflange II Acetabular Cup System, DePuy Orthopaedics, Inc. (2004) Summary page 5.

## Indications for use
The TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty. The TriFlange Hip Prosthesis is indicated in the following conditions: 1. Where bones loss is present in the acetabular region 2. Pelvic discontinuities Porous-coated TriFlange Hip Prostheses are indicated for cementless applications. The system is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Porous-coated TriFlange Hip Prostheses are indicated for cement-less applications.

Source page: https://510kreport.com/device/K232556
Methodology: https://510kreport.com/methodology