# K083642: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 6, 2009 after 87 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K881288 (1988). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062426: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K023786: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liner, DePuy Orthopaedics, Inc. (2002) Summary page 1.
- K003523: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K002883: Pinnacle Metal-on-Metal Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K082446: Biomet Metal-on-Metal Hip Systems- Expanded Contraindications, Biomet, Inc. (2008) Summary page 1.

## Indications for use
The Pinnacle Metal-on-Metal Acetabular Cup Liners are indicated for use as the acetabular component 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 non-union of fernoral fractures. Use of the prosthesis is also indicated 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. The Pinnacle Metal-on-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.

Source page: https://510kreport.com/device/K083642
Methodology: https://510kreport.com/methodology