# K020580: X-Series BI-Metric Hip Femoral Components

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Mar 22, 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921224 (1994). 1 ancestor in all.
17 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921224: Bimetric Total Hip System, Biomet, Inc. (1994) Summary page 1.

## Most influential descendants
- K062775: European Style Taper,Press-Fit Hip Stem (2007), 13 descendants of its own
- K131022: Ovation 10/12 Hip Stem (2013), 5 descendants of its own
- K141001: Alpine Hip Stem; Alpine HA Hip Stem (2014), 4 descendants of its own
- K173880: Corin TriFit CF Hip Stem (2018), 3 descendants of its own
- K133386: Ovation Tribute Hip Stem; Ovation Narrow Hip Stem (2014), 3 descendants of its own

## 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/K020580
Methodology: https://510kreport.com/methodology