# K970200: Reliance PF Femoral Stems

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Apr 9, 1997 after 78 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903563 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903563: Howmedica HNR System, Howmedica Corp. (1991) Summary page 1.
- K936126: Howmedics DRG Femoral Component, Howmedica, Inc. (1994) Summary page 1.
- K936127: Howmedica Premium Femoral Component, Howmedica, Inc. (1994) Summary page 1.
- (no number) Dow Corning Wright's McCutchen Hip System: named in the summary without a submission number

## Recalls of this device
- Aug 24, 2005 · Not classified · Z-0108-06: The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

## Indications for use
The Reliance® PF stem is a femoral component of a Total Hip System. It is intended to be used for primary or secondary reconstruction of the proximal femur damaged as a result of inflammatory, non-inflammatory, or traumatic joint disease. The Reliance® PF stem is intended to be used in conjunction with Howmedica's V40 femoral heads, Acetabular components, and unipolar and bipolar components. The stem can be press-fit into the proximal femur for fixation by mechanical interlock, or affixed with bone cement.

Source page: https://510kreport.com/device/K970200
Methodology: https://510kreport.com/methodology