# K040047: Polygraft BGS; Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Osteobiologics, Inc.
- Decided: Dec 17, 2004 after 340 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: 3 generations back to K960978 (1996). 4 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030288: Polygraft Bone Graft Substitute, Osteobiologics, Inc. (2003) Summary page 1.

## Most influential descendants
- K063359: INQU (2007), 13 descendants of its own
- K071428: INQU (2007), 11 descendants of its own
- K103799: Inqu Paste Mix Plus (2011), 9 descendants of its own
- K130392: Kinex Bioactive (2013), 8 descendants of its own
- K060917: Kensey Nash Bone Void Filler (2006), 7 descendants of its own

## Recalls of this device
- Sep 29, 2006 · Not classified · Z-0440-2007: Mis-packaging-product in the package may be a different size than indicated on the labeling.

## Indications for use
The PolyGraftTM BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraftTM BGS is intended to 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 with bone during the healing process. The PolyGraft TM BGS may be combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.

Source page: https://510kreport.com/device/K040047
Methodology: https://510kreport.com/methodology