# K001277: Triflange Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 23, 2000 after 63 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: 3 generations back to K941847 (1994). 10 ancestors in all.
213 later devices descend from it; 3 cite it directly.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952740: Depuy Duraloc 400 Acetabular Cup, Depuy, Inc. (1995) Summary page 1.
- K962007: Protrusion Cages, Depuy, Inc. (1996) Summary page 1.
- K983035: Custom Flanged Acetabular Component, Biomet, Inc. (1998) Summary page 1.
- K972393: Inter-OP HA Porous Acetabular System (HA/Csti), Sulzer Orthopedics, Inc. (1997) Summary page 1.
- K980711: Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating, Zimmer, Inc. (1998) Summary page 1.

## Most influential descendants
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis (2003), 207 descendants of its own
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head (2006), 90 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own

## Indications for use
The TriFlange™ Acetabular Cup System is intended to be used with the Duraloc® polyethylene liners to resurface the acetabular socket in cementless application during total hip arthroplasty. The device is indicated for use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged by disease, deformity, or trauma including non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.

Source page: https://510kreport.com/device/K001277
Methodology: https://510kreport.com/methodology