# K041616: Bgran Synthetic Osteoconductive Scaffoid

- Pathway: 510(k) (Traditional)
- Applicant: Orthos (Uk) Limited
- Decided: Aug 25, 2004 after 71 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: 2 generations back to K013072 (2002). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 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.
- K014156: Cerasorb Ortho, Curasan AG (2002) Summary page 2.

## Most influential descendants
- K143692: GranOSTM - beta tricalcium phosphate synthetic bone granules (2015), 0 descendants of its own
- K061311: Allogran-R (2006), 0 descendants of its own

## Indications for use
OIGran Synthetic Osteoconductive Scaffold Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. flGran Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. BGran Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. BGran Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K041616
Methodology: https://510kreport.com/methodology