# K170917: Bi-Ostetic Bioactive Glass Foam

- Pathway: 510(k) (Traditional)
- Applicant: Berkeley Advanced Biomaterials
- Decided: Oct 30, 2017 after 215 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960978 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050789: Formagraft Collagen Bone Graft Matrix, R and D Medical, LLC (2005) Summary page 5.
- K092046: BI-Ostetic Foam and Putty, Generos Foam and Putty, Berkeley Advanced Biomaterials, Inc. (2010) Summary page 5.

## Recalls of this device
- Sep 2, 2025 · Class II · Z-0540-2026: Due to incorrect product label (Incorrect product name identified on outer packaging).

## Indications for use
Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone, and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.

Source page: https://510kreport.com/device/K170917
Methodology: https://510kreport.com/methodology