# K071583: Cermet Iii Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Implants International, Ltd.
- Decided: Jul 25, 2007 after 47 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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 K941141 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040412: Trident T Acetabular Shells, Stryker Orthopaedics (2004) Summary page 1.

## Indications for use
The CER-METTM III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.

Source page: https://510kreport.com/device/K071583
Methodology: https://510kreport.com/methodology
