# K030554: Callos

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Kinetics, LLC
- Decided: May 20, 2003 after 88 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 K011897 (2001). 1 ancestor in all.
11 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)
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001)

## Most influential descendants
- K051123: Callos Impact and Inject Bone Void Filler (2005), 9 descendants of its own
- K042072: Callos CMF Bone Void Filler (2004), 3 descendants of its own
- K051784: Osteovation CMF Bone Void Filler (2005), 2 descendants of its own
- K162864: OsteoVation Impact (2017), 1 descendant of its own
- K132211: Skaffold NMX Bone Void Filler (2014), 1 descendant of its own

## Indications for use
Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K030554
Methodology: https://510kreport.com/methodology