# K013764: Immix Bone Graft Extender

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Biomedical, Inc.
- Decided: May 16, 2002 after 184 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- 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 K904111 (1990). 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)
- K904111: HTR Polymer, HTR-MX, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.

## Indications for use
As a spacemaking device used in cranio-facial guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation. Not to be used in load-bearing areas.

Source page: https://510kreport.com/device/K013764
Methodology: https://510kreport.com/methodology