# K961388: Atlas Iii Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres
- Decided: Apr 3, 1997 after 358 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: 1 generation back to K911728 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912452: HA Mccutchen SLT Hip System, Dow Corning Wright (1991) Summary page 1.
- K911728: Omnifit (R) Epf Dual Geomtry/Radius/Thread Acetab C, Osteonics Corp. (1991) Summary page 1.
- K954023: Osteonics Secur-Fit HA PSL Extra Acetabular Component System, Osteonics Corp. (1995) Summary page 1.

## Indications for use
The ATLAS® III Acetabular Cup is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, and revision of previously failed hip arthroplasties. The device is designed for cementless application.

Source page: https://510kreport.com/device/K961388
Methodology: https://510kreport.com/methodology