# K240459: Cerament Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Bonesupport AB
- Decided: Mar 5, 2024 after 18 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: 26 generations back to K841189 (1984). 373 ancestors in all.
No later device cites it as a predicate yet.
1 of 374 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 5.
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty, Depuy Spine (2022) Summary page 5.

## 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, posterolateral spine (only during open surgery in spine), and intervertebral disc space. 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. When used in intervertebral body fusion procedures, CERAMENT BONE VOID FILLER must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. 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/K240459
Methodology: https://510kreport.com/methodology