# K003447: Protract Press Fit Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Dec 15, 2000 after 39 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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. Joint impairment from arthritis (rheumatoid, osteo and posttraumatic). 2. Revision of failed femoral head replacements. 3. When alternative reconstructive techniques are not viable. 4. When arthrodesis is contraindicated. 5. Avascular necrosis or fracture of the femoral head. 6. Congenital defects that will allow adequate function of the system.

Source page: https://510kreport.com/device/K003447
Methodology: https://510kreport.com/methodology