# K040383: Triflange II Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 12, 2004 after 85 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: 4 generations back to K930712 (1993). 19 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K001277: Triflange Acetabular Cup System, DePuy Orthopaedics, Inc. (2000)
- K001534: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000)

## Most influential descendants
- K201348: DePuy 3D Additive TriFlange Acetabular Cup (2022), 1 descendant of its own
- K232556: DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System (2023), 0 descendants of its own

## Indications for use
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 femnoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.

Source page: https://510kreport.com/device/K040383
Methodology: https://510kreport.com/methodology