# K014049: Epoca Codr Stem and Head

- Pathway: 510(k) (Special)
- Applicant: Stelkast Company
- Decided: Jan 9, 2002 after 30 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EPOCA Custom Offset Shoulder Systsem can be used for either hemi or total shoulder replacement. It is a single-use device intended for cemented recoustruction of the humeral portion of severely destroyed (4-part fractures) and/or disabled and/or very painful shoulder joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present. This device is intended for use with components of the EPOCA Custom Offset Shoulder System only.

Source page: https://510kreport.com/device/K014049
Methodology: https://510kreport.com/methodology