# K093390: Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: May 25, 2010 after 208 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K960978 (1996). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081432: Healos II Bone Graft Substitute, Depuy Spine, Inc. (2008) Summary page 1.

## Indications for use
HEALOS Dental Bone Graft Material ("HEALOS"), is intended to fill, augment, or reconstruct periodontal and/or bony defects of the upper or lower jaw. HEALOS is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.

Source page: https://510kreport.com/device/K093390
Methodology: https://510kreport.com/methodology