Bonesupport AB: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Bonesupport AB” (first 2005, latest 2024), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 108 days. Since 2017 the median was 85 days, against 95 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 130 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 52 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bonesupport AB took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 95 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 5 | 5 |
| QRR | Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside | 2 | 1 |
Review panels
- Orthopedic (7)
Most recent Bonesupport AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234008 | CERAMENT G | QRR | 2024-03-13 | 85 |
| K240459 | Cerament Bone Void Filler | MQV | 2024-03-05 | 18 |
| K201535 | Cerament Bone Void Filler | MQV | 2020-10-16 | 130 |
| K090871 | CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 | MQV | 2009-09-04 | 158 |
| K073316 | CERAMENT BONE VOID FILLER, MODEL A0210 | MQV | 2008-06-20 | 207 |
| K051951 | CERAMENT BONE VOID FILLER | MQV | 2005-09-28 | 72 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210044 | De Novo | Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside | 2022-05-17 |
Recalls
openFDA lists no recalls under a recalling firm named Bonesupport AB.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Bonesupport AB is the lead sponsor of 4 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06555848: CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure (Recruiting, started 2025-06-02)
- NCT06010433: CERAMENT G Device Registry (Recruiting, started 2023-08-17)
- NCT04244942: CERAMENT™| Bone Void Filler Device Registry (Recruiting, started 2020-03-30)
- NCT02820363: Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures (Completed, started 2017-02-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bonesupport AB?
FDA lists 6 510(k) clearances under the applicant name “Bonesupport AB” (first 2005, latest 2024), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bonesupport AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bonesupport AB is 108 days. Since 2017: 85 days, versus 95 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bonesupport AB?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 5); QRR (Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside, 2).
Next steps
- See all 6 Bonesupport AB clearances with predicates and recalls
- Run predicate analysis for product code MQV, Bonesupport AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.