# K073499: Versys Epoch Fullcoat Hip Prosthesis, Model 4088 Series

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 7, 2008 after 238 days
- Product code: JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3320
- 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 K842906 (1984). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052321: Versys Epoch Fullcoat Hip Prosthesis, Zimmer, Inc. (2006)

## Indications for use
The VerSys Epoch FullCoat Hip Prosthesis is indicated for: - Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. - Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. - Patients suffering from disability due to previous fusion. - Patients with acute femoral neck fractures. This device is intended for cementless use only.

Source page: https://510kreport.com/device/K073499
Methodology: https://510kreport.com/methodology