# K953268: Dual Taper Wedge Pressed Fit Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Jan 17, 1996 after 188 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 31, 2008 · Not classified · Z-1073-2009: A possible breach of the sterile barrier packaging (Tyvek pouch).
- Oct 7, 2008 · Not classified · Z-0664-2009: Sterility may be compromised due to breach in packaging.

Source page: https://510kreport.com/device/K953268
Methodology: https://510kreport.com/methodology