# K971435: Headloc Ceramic Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jul 9, 1997 after 82 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Headloc™ Ceramic Femoral Head for the Primaloc™ Cementless Hip System is intended for single-use cementless implantation during primary/revision surgery. The Ceramic Head allows for primary articulation between the acetabular cup and femoral stem to restore patient mobility. Indications for use are: - Osteoarthritis, rheumatoid arthritis, or other osteoarthroses; - Certain femoral neck fractures or dislocations; - Post-traumatic arthritis; - Idiopathic avascular necrosis of the femoral head; - Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis; - Previous failed surgery; - Total hip replacement where the surgeon indicates a ceramic head The Headloc™ Ceramic Head may be used with the Primaloc™ Cemetless Hip System which is cleared for use under Premarket Notification K953977.

Source page: https://510kreport.com/device/K971435
Methodology: https://510kreport.com/methodology