# K201219: Biocore9 Femoral Head Resurfacing Component

- Pathway: 510(k) (Traditional)
- Applicant: Biocore9, LLC
- Decided: Jan 19, 2021 after 258 days
- Product code: KXA (Prosthesis, Hip, Femoral, Resurfacing)
- Device class: 2
- Regulation: 21 CFR 888.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904870 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904870: Modified New Jersey Femoral Hip Resurfacing Compon, Endotec, Inc. (1991) Summary page 4.

## Indications for use
The Biocore9 Femoral Resurfacing Head Component, used with cement, is indicated for the treatment of painful hip arthritis due to post-traumatic arthritis, osteoarthritis, or rheumatoid arthritis, as well as painful hip arthroplasty when sufficient femoral head and neck stock exist to stabilize a resurfacing femoral head. The Biocore9 Femoral Resurfacing Head Component is intended for cemented use only. This device is intended for hemi-arthroplasty only.

Source page: https://510kreport.com/device/K201219
Methodology: https://510kreport.com/methodology