# K061311: Allogran-R

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Sep 22, 2006 after 135 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: 3 generations back to K013072 (2002). 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)
- K032409: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita, Inc. (2003) Summary page 1.
- K041616: Bgran Synthetic Osteoconductive Scaffoid, Orthos (Uk) Limited (2004) Summary page 1.

## Indications for use
Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., the extremities, spine or pelvis) and may be combined with saline or blood. Defects may be due to trauma or surgery.

Source page: https://510kreport.com/device/K061311
Methodology: https://510kreport.com/methodology