# K100841: Boneoptimizer

- Pathway: 510(k) (Special)
- Applicant: Curasan AG
- Decided: Aug 19, 2010 after 147 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 K014156 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014156: Cerasorb Ortho, Curasan AG (2002) Summary page 1.
- K040216: Cerasorb M Ortho, Curasan AG (2004) Summary page 1.

## Indications for use
Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.

Source page: https://510kreport.com/device/K100841
Methodology: https://510kreport.com/methodology