# K810258: Proximal Fermoral Hip Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 5, 1981 after 34 days
- Product code: JDO (Device, Fixation, Proximal Femoral, Implant)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
509 later devices descend from it; 1 cites it directly.
0 of 510 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
- K974558: Salvage/Onocology Hip and Total Femur System (1998), 508 descendants of its own
- K032396: Ringloc 36MM Line and Modular Femoral Heads (2003), 505 descendants of its own
- K042051: Arcomxl Polyethylene Liners (2005), 355 descendants of its own
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own

Source page: https://510kreport.com/device/K810258
Methodology: https://510kreport.com/methodology