Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bonesupport AB — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
231 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234008 | CERAMENT G | Bonesupport AB | 2024-03-13 | 85 | 0 |
| K240459 | Cerament Bone Void Filler | Bonesupport AB | 2024-03-05 | 18 | 0 |
| DEN210044 | CERAMENT G | Bonesupport AB | 2022-05-17 | 231 | 0 |
| K201535 | Cerament Bone Void Filler | Bonesupport AB | 2020-10-16 | 130 | 0 |
| K090871 | CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 | Bonesupport AB | 2009-09-04 | 158 | 0 |
| K073316 | CERAMENT BONE VOID FILLER, MODEL A0210 | Bonesupport AB | 2008-06-20 | 207 | 0 |
| K051951 | CERAMENT BONE VOID FILLER | Bonesupport AB | 2005-09-28 | 72 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda