# K921224: Bimetric Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 16, 1994 after 705 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
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices 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.

## Most influential descendants
- K020580: X-Series BI-Metric Hip Femoral Components (2002), 17 descendants of its own
- 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

Source page: https://510kreport.com/device/K921224
Methodology: https://510kreport.com/methodology