# K001534: Pinnacle Acetabular System

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 12, 2000 after 26 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 K930712 (1993). 7 ancestors in all.
267 later devices descend from it; 15 cite it directly.
0 of 275 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K031110: Apex Modular Acetabular Cup (2003), 217 descendants of its own
- K040544: Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062 and 1599-21-044 to -062 (2004), 118 descendants of its own
- K093472: Trinity Acetabular System (2010), 117 descendants of its own
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own
- K071784: Depuy Pinnacle with Gripton Acetabular Cups (2007), 72 descendants of its own

## Indications for use
The DePuy Pinnacle Acetabular System is intended to be used to resurface the acetabular socket in cemented or cementless total hip arthroplasty. The Pinnacle Acetabular System is indicated for total hip replacement 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, herniarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain casesof ankylosis. All Pinnacle porous-coated acetabular shells are indicated for cementless application.

Source page: https://510kreport.com/device/K001534
Methodology: https://510kreport.com/methodology