# DEN210044: Cerament G

- Pathway: De Novo (Direct)
- Applicant: Bonesupport AB
- Decided: May 17, 2022 after 231 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K234008: Cerament G (2024), 0 descendants of its own

## Indications for use
CERAMENT G is a resorbable, gentamicin-eluting ceramic bone void filler intended for use as a bone void filler in skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis in defects in the extremities. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis 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/DEN210044
Methodology: https://510kreport.com/methodology