# K062426: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 15, 2006 after 119 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: 3 generations back to K004043 (2001). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K040627: Depuy Asr Modular Acetabular Cup System, DePuy Orthopaedics, Inc. (2005) Summary page 1.

## Most influential descendants
- K091973: Metasul Taper Liners, Metasul Femoral Heads (2009), 0 descendants of its own
- K083642: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners (2009), 0 descendants of its own

## 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 femoral fractures Use of the prosthesis is also indicated for patients with congenital hip dysplasia. prwrusio acerabu/i, 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 DcPuv Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.

Source page: https://510kreport.com/device/K062426
Methodology: https://510kreport.com/methodology