# K243609: EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )

- Pathway: 510(k) (Special)
- Applicant: Etex Corporation
- Decided: Dec 18, 2024 after 26 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: 10 generations back to K960978 (1996). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen, Etex Corp. (2010) Summary page 5.
- K082793: Intergro DBM, Biomet Spine (2009) Summary page 5.

## Indications for use
EquivaBone is a bone graft substitute that combines synthetic calcium phosphate and demineralized bone. It 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 defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Source page: https://510kreport.com/device/K243609
Methodology: https://510kreport.com/methodology