# K904870: Modified New Jersey Femoral Hip Resurfacing Compon

- Pathway: 510(k) (Traditional)
- Applicant: Endotec, Inc.
- Decided: May 23, 1991 after 212 days
- Product code: KXA (Prosthesis, Hip, Femoral, Resurfacing)
- Device class: 2
- Regulation: 21 CFR 888.3400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K201219: Biocore9 Femoral Head Resurfacing Component (2021), 0 descendants of its own

## Recalls of this device
- Jun 5, 2009 · Not classified · Z-1627-2010: Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
- Jun 5, 2009 · Not classified · Z-1625-2010: Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
- Jun 5, 2009 · Not classified · Z-1624-2010: Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

Source page: https://510kreport.com/device/K904870
Methodology: https://510kreport.com/methodology