# K014156: Cerasorb Ortho

- Pathway: 510(k) (Traditional)
- Applicant: Curasan AG
- Decided: Mar 18, 2002 after 89 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.
16 later devices descend from it; 8 cite it directly.
0 of 17 devices 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) Vitoss™ Scaffold: named in the summary without a submission number

## Most influential descendants
- K050260: Bioresorb Macro Pore (2005), 4 descendants of its own
- K030178: Calcigen Psi Bone Graft Substitute (2003), 3 descendants of its own
- K042305: Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901, Ossaplast Ortho, 3.0ML, Model# 221 903 (2004), 2 descendants of its own
- K041616: Bgran Synthetic Osteoconductive Scaffoid (2004), 2 descendants of its own
- K083372: Arrowbone-a, Arrowbone-B (2009), 1 descendant of its own

## Indications for use
Cerasorb ORTHO in granular form is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the hony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous bload (Wood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone. Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required. Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and. replaced with new bone.

Source page: https://510kreport.com/device/K014156
Methodology: https://510kreport.com/methodology