# K070864: Boneplast QS Calcium Sulfate Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Osteobiologics
- Decided: Jun 1, 2007 after 65 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013790: Calcigen-S Bone Void Filer, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K024336: Miig II Bone Graft Substitute, Wrightmedicaltechnologyinc (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K060011: Miig SR, Wrightmedicaltechnologyinc (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
BonePlast® QS Bone Void Filler is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the stability of the bone structure (i.e., the extremities, spine and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only.

Source page: https://510kreport.com/device/K070864
Methodology: https://510kreport.com/methodology