# K090855: Equivabone Osteoinductive Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Etex Corp.
- Decided: Sep 18, 2009 after 172 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: 7 generations back to K960978 (1996). 31 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063050: Cap Plus, Etex Corp. (2007) Summary page 1.
- K080329: Cap Plus, Equivabone, Cap/DBM, Etex Corp. (2008) Summary page 1.
- K090310: Equivabone, Etex Corp. (2009) Summary page 1.
- K082575: Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes, Apatech, Ltd. (2008)
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K130392: Kinex Bioactive (2013), 8 descendants of its own
- K102528: N-Force Fixation System (2011), 5 descendants of its own

## Indications for use
EquivaBone is an osteoinductive bone graft substitute that is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine) and pelvis that are not intrinsic to the stability of the bony structure. These voids or gaps may result from natural occurring bone disease, traumatic injury or surgical intervention.

Source page: https://510kreport.com/device/K090855
Methodology: https://510kreport.com/methodology