# K053213: BI-Ostetic Foam, Cem-Ostetic Foam, Tri-Ostetic Foam, Generos Foam

- Pathway: 510(k) (Traditional)
- Applicant: Berkeley Advanced Biomaterials, Inc.
- Decided: Jul 6, 2006 after 232 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 no predicate by number.

## Indications for use
Bi-Ostetic Foam is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Bi-Ostetic Foam is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Bi-Ostetic Foam should not exceed 30 mL.

Source page: https://510kreport.com/device/K053213
Methodology: https://510kreport.com/methodology