# K942027: Impact CO-CR 1-Piece Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 19, 1994 after 146 days
- Product code: JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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; 2 cite 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980020: Activelock Modular Femoral Hip System (1998), 2 descendants of its own
- K992815: The Margron Hip Replacement System (2000), 1 descendant of its own
- K032641: Modification to: the Margron Hip Replacement System (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K942027
Methodology: https://510kreport.com/methodology