# K201348: DePuy 3D Additive TriFlange Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Depuy International, Ltd.
- Decided: Jun 16, 2022 after 756 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: 5 generations back to K930712 (1993). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040383: Triflange II Acetabular Cup System, DePuy Orthopaedics, Inc. (2004) Summary page 4.

## Most influential descendants
- K232556: DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System (2023), 0 descendants of its own

## 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 bone loss is present in the acetabular region 2. Pelvic discontinuities Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.

Source page: https://510kreport.com/device/K201348
Methodology: https://510kreport.com/methodology