# K012751: Healos Bone Graft Material

- Pathway: 510(k) (Traditional)
- Applicant: Orquest, Inc.
- Decided: Nov 14, 2001 after 90 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: 3 generations back to K960978 (1996). 9 ancestors in all.
84 later devices descend from it; 11 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.
- K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L, Interpore Intl. (1998) Summary page 1.
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.
- K000515: Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,, Interpore Cross Intl. (2000) Summary page 2.
- K974399: Bio-Oss Collagen, Geistlich-Pharma (1998) Summary page 1.
- K003339: Collagen Periodontal Membrane, Collagen Matrix, Inc. (2001) 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). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K043308: Modification to: Healos Bone Graft Material (2005), 67 descendants of its own
- K051386: Mastergraft Putty Bone Void Filler (2005), 59 descendants of its own
- K033679: Copsios Bone Void Filler (BVF) (2004), 54 descendants of its own
- K071813: Mastergraft Putty (2007), 47 descendants of its own
- K052812: Ossimend (TM) Bone Graft Material (2006), 40 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 healing process.

Source page: https://510kreport.com/device/K012751
Methodology: https://510kreport.com/methodology