# K040600: Genex Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: May 7, 2004 after 60 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 K994337 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021551: Stimulan - Calcium Sulfate Bone Void Filler Kit, Biocomposites, Ltd. (2002) Summary page 1.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.
- K031040: Therifil Bone Filler, Therics, Inc. (2003) Summary page 1.
- K022622: Cem-Ostetic, Models Cemo-020O, Cemo-05P, Cemo-10P, Cemo-20P, and Cemo-30P, Berkeley Advanced Biomaterials, Inc. (2003) Summary page 1.

## Indications for use
Genex ® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure. Genex7 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 ® provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Genex ® is provided sterile for singe use only.

Source page: https://510kreport.com/device/K040600
Methodology: https://510kreport.com/methodology