# K031651: Modification to Cerasorb Ortho

- Pathway: 510(k) (Special)
- Applicant: Curasan AG
- Decided: Aug 13, 2003 after 77 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cerasorb ORTHO (granular form): named in the summary without a submission number

## Indications for use
Cerasorb ORTHO (granular or block forms) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the β-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb ORTHO should not be in dry form, the material should be mixed with autologous blood.

Source page: https://510kreport.com/device/K031651
Methodology: https://510kreport.com/methodology