# K234008: Cerament G

- Pathway: 510(k) (Traditional)
- Applicant: Bonesupport AB
- Decided: Mar 13, 2024 after 85 days
- Product code: QRR (Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside)
- Device class: 2
- Regulation: 21 CFR 888.3046
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN210044 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210044: Cerament G, Bonesupport AB (2022) Summary page 5.

## Indications for use
CERAMENT G is a resorbable, gentamicin-eluting ceramic bone void filler intended for use in defects in the extremities of skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement as part of the standard treatment approach to bone infection and open fractures. By eluting gentamicin, CERAMENT G can reduce the occurrence and reoccurrence of bone infection from gentamicin-sensitive microorganisms in order to protect bone healing. CERAMENT G can augment provisional hardware to help 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 G resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K234008
Methodology: https://510kreport.com/methodology