# K043514: Allogran-N-Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Jan 21, 2005 after 32 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Apatight™-HA Bone Graft Substitute: named in the summary without a submission number
- (no number) ApaPore® Bone Graft Substitute: named in the summary without a submission number

## Indications for use
Allogran-N TM is intended for use as a bone void filler or bone void substitute for bony voids or gaps that are not intrinsic to the stability of the bony structure. Allogran-N TM is to be packed into bony voids or gaps in the skeletal system (e.g., the spine, pelvis and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. Allogran-NTM is completely incorporated with new bone during the healing process.

Source page: https://510kreport.com/device/K043514
Methodology: https://510kreport.com/methodology