# K953925: Fine Grain Cast Cobalt Chromium Hip Stems

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 31, 1996 after 166 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K063002: Altra Press-Fit Hip System (2006), 3 descendants of its own
- K070274: Echo BI-Metric Press-Fit Stems (2007), 2 descendants of its own
- K143009: Echo Bi-Metric Microplasty Hip System (2014), 1 descendant of its own
- K150503: Echo Bi-Metric Microplasty Line Extension (2015), 0 descendants of its own
- K030087: Spinal Concepts, Inc. Bacfix TI Spinal System (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K953925
Methodology: https://510kreport.com/methodology