# K031319: Osteo-G Bone Void Filler System

- Pathway: 510(k) (Traditional)
- Applicant: Aspine USA, Inc.
- Decided: Jul 17, 2003 after 83 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 K963587 (1997). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010557: Jax Granules Bone Void Filler, Smith & Nephew, Inc. (2001) Summary page 3.
- K963562: Wright Plaster of Paris Pellets, Wrightmedicaltechnologyinc (1997) Summary page 3.
- K963587: Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision), Wrightmedicaltechnologyinc (1997) Summary page 3.
- K010532: Osteoset BVF Kit, Wrightmedicaltechnologyinc (2001)
- K991854: Osteoplast, Model POP200, Interpore Cross Intl. (1999) Summary page 3.
- K003954: Stimulan - Calcium Sulfate Bone Void Filler Kit, Biocomposites, Ltd. (2001) Summary page 3.
- K013790: Calcigen-S Bone Void Filer, Biomet Orthopedics, Inc. (2002) Summary page 3.

## Most influential descendants
- K091688: A-Grix Resorbable Bone Void Filler (2010), 1 descendant of its own
- K121453: A-Grix TE Resorable Bone Void Filler (2013), 0 descendants of its own
- K072444: Wellgraft PE I (2008), 0 descendants of its own
- K072170: Wellgraft PE II (2008), 0 descendants of its own

## Indications for use
The Osteo-G Bone Void Filler System, pellets or paste, are intended for filling of bony vloids or gaps, i. e., of the extremities, spine or pelvis, that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets or paste provide a bone void filler that is bioabsorbable and is replaced with bone during the healing process. Osteo-G Bone Void Filler System pellets or paste may be used at an infected site.

Source page: https://510kreport.com/device/K031319
Methodology: https://510kreport.com/methodology