# K081758: Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Sep 3, 2008 after 75 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: 6 generations back to K960978 (1996). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 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.
- K062495: Healos FX Bone Graft Substitute and Graft Mixing and Delivery System, Depuy Spine, Inc. (2006) Summary page 1.
- K003286: Symphony Graft Delivery System, Depuyacromed (2001) Summary page 1.
- K043261: Harvest Graft Delivery Syringe, Harvest Technologies, Corp. (2005) Summary page 1.
- K030208: Imbibe II Syringe, Orthovita, Inc. (2003) Summary page 1.

## Indications for use
HEALOS ® Fx Injectable Bone Graft Replacement ("HEALOS Fx"), 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 Fx is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process. The HEALOS® Fx Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® Fx Injectable Bone Graft Replacement to a surgical site.

Source page: https://510kreport.com/device/K081758
Methodology: https://510kreport.com/methodology