# K092046: BI-Ostetic Foam and Putty, Generos Foam and Putty

- Pathway: 510(k) (Special)
- Applicant: Berkeley Advanced Biomaterials, Inc.
- Decided: Mar 24, 2010 after 261 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K170917: Bi-Ostetic Bioactive Glass Foam (2017), 0 descendants of its own

## Indications for use
Bi-Ostetic Foam (or Putty) 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, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous detects 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. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.

Source page: https://510kreport.com/device/K092046
Methodology: https://510kreport.com/methodology