# K934515: Bias (TM) Fiber Metal Total Hip Stem (TFB)

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 7, 1995 after 538 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K014070: Epoch Hip Prosthesis, Model 4075 Series (2002), 2 descendants of its own
- K052321: Versys Epoch Fullcoat Hip Prosthesis (2006), 1 descendant of its own
- K073499: Versys Epoch Fullcoat Hip Prosthesis, Model 4088 Series (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K934515
Methodology: https://510kreport.com/methodology