510(k) · Cleared
ClearedCerament G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonesupport AB · QRR Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Cleared on Mar 13, 2024 as substantially equivalent to DEN210044 (Bonesupport AB, 2022) after an 85-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Mar 13, 2024
- Review
- 85 days
- Class
- Class II
- Product code
- QRR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN210044 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backDEN210044 Cerament GBonesupport AB · 2022
- This deviceK234008 Cerament GBonesupport AB · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN210044 | Cerament G | Bonesupport AB | 2022 | — |
| 0 (this device) | K234008 | Cerament G | Bonesupport AB | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN210044 | Cerament GSummary page 5…ontaining a single approved aminoglycoside antibacterial. Classification: Class II Product Code: QRR Primary Predicate: CERAMENT G (DEN210044) Indications For Use: CERAMENT G is a resorbable, gentamicin-eluting ceramic bone void filler intended for use in defects in th… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QRR devicesQRR Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QRR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QRR
Too few QRR 510(k)s in any year since 2007 to give a median.
Recalls per year · QRR
No recall names QRR since 2007.
Adverse event reports per year · QRR
3in 2025
MAUDE reports naming product code QRR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (117 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234008: Cerament G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234008
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026