# K070220: Osteofix Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Calcitec, Inc.
- Decided: Apr 12, 2007 after 79 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: 1 generation back to K990131 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.
- K040405: Cem-Ostetic Putty Injection Kit, Model Pik-XX, Pik-XX-YY, Berkeley Advanced Biomaterials, Inc. (2004) Summary page 1.
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001)

## Indications for use
OsteofixTM Bone Void Filler is indicated for use to fill bony voids or gaps that are not intrinsic to the stability of the bony structure. OsteofixTM Bone Void Filler is intended to be injected 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/K070220
Methodology: https://510kreport.com/methodology