# K051951: Cerament Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Bonesupport AB
- Decided: Sep 28, 2005 after 72 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: 4 generations back to K960978 (1996). 12 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024336: Miig II Bone Graft Substitute, Wrightmedicaltechnologyinc (2003) Summary page 1.
- K010532: Osteoset BVF Kit, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K022622: Cem-Ostetic, Models Cemo-020O, Cemo-05P, Cemo-10P, Cemo-20P, and Cemo-30P, Berkeley Advanced Biomaterials, Inc. (2003) Summary page 1.
- K023862: Norian XR Calcium Phosphate Bone Void Filler, Synthes (Usa) (2002) Summary page 1.
- K033722: Apapore Bone Graft Substitute, Apatech, Ltd. (2004) Summary page 1.
- K961511: Hapset Hydroxylapatite Bone Graft Plaster, Lifecore Biomedical, Inc. (1996) Summary page 1.

## Most influential descendants
- K073316: Cerament Bone Void Filler, Model A0210 (2008), 6 descendants of its own
- K201535: Cerament Bone Void Filler (2020), 3 descendants of its own
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own
- K071004: Osteocrete Bone Void Filler (2009), 2 descendants of its own
- K223915: Tactoset (2023), 1 descendant of its own

## Indications for use
Cerament™ is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Cerament™ is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone. Cerament™ provides a bone void filler that resorbs and is replaced by bone during the healing process

Source page: https://510kreport.com/device/K051951
Methodology: https://510kreport.com/methodology