# K934457: Stability Hip Stem with Porocoat

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jul 6, 1994 after 296 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915787 (1993). 1 ancestor in all.
194 later devices descend from it; 4 cite it directly.
1 of 196 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915787: Stability Hip Stem with Porocoat, Depuy, Inc. (1993) Summary page 4.
- (no number) AML Porocoat Femoral Stem: named in the summary without a submission number

## Most influential descendants
- K001991: Titan Porocoat Hip Prosthesis (2000), 188 descendants of its own
- K042992: Corail Amt Hip Prosthesis (2005), 168 descendants of its own
- K082525: Corin Metafix Femoral Stem (2010), 71 descendants of its own
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty (2012), 61 descendants of its own
- K070554: Depuy Corail Amt Dysplasia Hip Prosthesis (2007), 49 descendants of its own

## Indications for use
The Stability Hip Prosthesis is indicated for uncemented use as the femoral component in total hip arthroplasty for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty. The articular surface of the prosthesis is provided by the attachment of a modular femoral head of cobalt-chromium-molybdenum alloy (Orthochrome) or aluminum oxide ceramic (Biolox) for use in total hip replacement with a porous coated metal-backed acetabular component with a bearing surface made of ultra high molecular weight polyethylene. Fixation of the Stability Hip to the skeleton is intended to be by uncemented, biological fixation by tissue ingrowth into the porous coating.

Source page: https://510kreport.com/device/K934457
Methodology: https://510kreport.com/methodology