# K000306: Pinnacle Acetabular System

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 23, 2000 after 51 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930712 (1993). 6 ancestors in all.
403 later devices descend from it; 18 cite it directly.
0 of 410 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983014: Summit Acetabular System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.

## Most influential descendants
- K001534: Pinnacle Acetabular System (2000), 267 descendants of its own
- K031110: Apex Modular Acetabular Cup (2003), 217 descendants of its own
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis (2003), 207 descendants of its own
- K042344: Excia Total Hip System (2005), 198 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

## Recalls of this device
- Nov 28, 2012 · Class II · Z-0569-2013: DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw 

## Indications for use
The Pinnacle Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. All Pinnacle porous-coated acetabular shells are indicated for cementless application.

Source page: https://510kreport.com/device/K000306
Methodology: https://510kreport.com/methodology