# K032110: Proclass Press  Fit Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Sep 22, 2003 after 75 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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
1. The ProClass Press Fit Hip Stem is a single use, cementless device used for reconstruction of the articulating surface of the femur portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head provided there is sufficient sound bone to seat the prosthesis. 2. The stem can be used for primary hip implant or for hip revision of a failed implant. 3. The stem can be used for congenital defects that will allow adequate function of the system.

Source page: https://510kreport.com/device/K032110
Methodology: https://510kreport.com/methodology