# K072355: Ossifuse Bone Substitute Material

- Pathway: 510(k) (Special)
- Applicant: Etex Corp.
- Decided: Sep 26, 2007 after 35 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: 2 generations back to K011048 (2001). 2 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033138: CAP3 Bone Substitute Material, Etex Corp. (2003) Summary page 1.

## Most influential descendants
- K090242: Gamma-BSM, Beta-BSM (2009), 25 descendants of its own
- K091607: Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone (2009), 22 descendants of its own
- K093447: Carrigen (2010), 21 descendants of its own
- K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen (2010), 10 descendants of its own
- K103799: Inqu Paste Mix Plus (2011), 9 descendants of its own

## Indications for use
OssiFuse Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as 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 created from traumatic injury to the bone. OssiFuse Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Source page: https://510kreport.com/device/K072355
Methodology: https://510kreport.com/methodology