# K030288: Polygraft Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Osteobiologics, Inc.
- Decided: Jul 17, 2003 after 170 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
Longest line of descent: 2 generations back to K960978 (1996). 3 ancestors in all.
33 later devices descend from it; 6 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963562: Wright Plaster of Paris Pellets, Wrightmedicaltechnologyinc (1997) Summary page 1.
- K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L, Interpore Intl. (1998) Summary page 1.

## Most influential descendants
- K040047: Polygraft BGS; Bone Graft Substitute (2004), 23 descendants of its own
- K063359: INQU (2007), 13 descendants of its own
- K071428: INQU (2007), 11 descendants of its own
- K033707: Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX (2004), 10 descendants of its own
- K103799: Inqu Paste Mix Plus (2011), 9 descendants of its own

## Indications for use
The PolyGraft 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 PolyGraft 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.

Source page: https://510kreport.com/device/K030288
Methodology: https://510kreport.com/methodology