# K071004: Osteocrete Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Bone Solutions, Inc.
- Decided: May 21, 2009 after 773 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: 5 generations back to K960978 (1996). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001) Summary page 1.
- K041842: Norian SRS Fast Set Putty, Synthes (Usa) (2004) Summary page 1.
- K051406: Osteocure Resorbable Bead Kit, Nexa Orthopedics, Inc. (2005) Summary page 1.
- K051951: Cerament Bone Void Filler, Bonesupport AB (2005) Summary page 1.

## Most influential descendants
- K212991: Osteorevive (2022), 1 descendant of its own
- K221256: Mg OSTEOINJECT (2022), 0 descendants of its own

## Indications for use
Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone 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. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Source page: https://510kreport.com/device/K071004
Methodology: https://510kreport.com/methodology