# K023409: HA X-Series BI-Metric Hip Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Nov 8, 2002 after 29 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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: 2 generations back to K921224 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020580: X-Series BI-Metric Hip Femoral Components, Biomet, Inc. (2002) Summary page 1.

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0523-2020: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

## Indications for use
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

Source page: https://510kreport.com/device/K023409
Methodology: https://510kreport.com/methodology