# K081432: Healos II Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Aug 29, 2008 after 100 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: 6 generations back to K960978 (1996). 34 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012751: Healos Bone Graft Material, Orquest, Inc. (2001) Summary page 1.
- K043308: Modification to: Healos Bone Graft Material, Depuy Spine, Inc. (2005) Summary page 1.
- K051617: Novabone Putty - Resorbable Bone Void Filler, Novabone Products, LLC (2006) Summary page 1.
- K063596: Perioglas Putty-Bioactive Bone Graft Gel, Novabone Products, LLC (2007) Summary page 1.
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 1.
- K014289: Orthoss Resorbable Bone Void Filler, Geistlich-Pharma (2002) Summary page 1.
- K000122: Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6 Strips Per Box), Neucoll, Inc. (2001)

## Most influential descendants
- K101827: Osteoscaf (2011), 1 descendant of its own
- K213260: CMFlexTM (2022), 0 descendants of its own
- K093390: Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025 (2010), 0 descendants of its own

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

Source page: https://510kreport.com/device/K081432
Methodology: https://510kreport.com/methodology