# K043308: Modification to: Healos Bone Graft Material

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Feb 16, 2005 after 77 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960978 (1996). 10 ancestors in all.
67 later devices descend from it; 6 cite it directly.
0 of 78 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.

## Most influential descendants
- K051386: Mastergraft Putty Bone Void Filler (2005), 59 descendants of its own
- K071813: Mastergraft Putty (2007), 47 descendants of its own
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own
- K060917: Kensey Nash Bone Void Filler (2006), 7 descendants of its own

## Indications for use
HEALOS Bone Graft Material ("HEALOS"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. 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/K043308
Methodology: https://510kreport.com/methodology