# K201535: Cerament Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Bonesupport AB
- Decided: Oct 16, 2020 after 130 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: 6 generations back to K960978 (1996). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073316: Cerament Bone Void Filler, Model A0210, Bonesupport AB (2008) Summary page 5.

## Most influential descendants
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own
- K223915: Tactoset (2023), 1 descendant of its own
- K231968: Tactoset® Injectable Bone Substitute (2023), 0 descendants of its own

## Indications for use
CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT | BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone. CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process. CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.

Source page: https://510kreport.com/device/K201535
Methodology: https://510kreport.com/methodology