# K082381: GENEX

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Nov 14, 2008 after 87 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K212721: Genex Bone Graft Substitute (2022), 0 descendants of its own

## Indications for use
Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure. Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, 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 cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K082381
Methodology: https://510kreport.com/methodology