# K041382: Polygraft BGS; Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Osteobiologics, Inc.
- Decided: Jun 17, 2005 after 388 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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
PolyGraftTm BGS Cement Restrictor is indicated for use as a bone cement flow restrictor plug in the femur, tibia, and/or humerus.

Source page: https://510kreport.com/device/K041382
Methodology: https://510kreport.com/methodology