# K212721: Genex Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Feb 4, 2022 after 161 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: 1 generation back to K082381 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082381: GENEX, Biocomposites, Ltd. (2008) Summary page 5.

## Indications for use
Genex® Bone Graft Substitute injectable paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. * Genex® Bone Graft Substitute is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure * Genex® Bone Graft Substitute is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extremities, posterolateral spine and pelvis) * Genex® Bone Graft Substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect * The bony defects or cavities may be surgically created or the result of traumatic injury. Genex® Bone Graft Substitute provides a bone graft substitute that resorbs and is replaced with bone during the healing process

Source page: https://510kreport.com/device/K212721
Methodology: https://510kreport.com/methodology