Bone Solutions, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Bone Solutions, Inc.” (first 2009, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 101 days. Since 2017 the median was 73 days, against 124 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 | 1 | 101 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 145 |
| 2021 | 0 | — |
| 2022 | 2 | 90 |
| 2023 | 0 | — |
| 2024 | 2 | 59 |
| 2025 | 1 | 150 |
| 2026 | 1 | 73 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bone Solutions, Inc. took a median 73 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 7 | 7 |
| FMF | Syringe, Piston | 2 | 2 |
Review panels
- Orthopedic (7)
- General Hospital (2)
Most recent Bone Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETE | MQV | 2026-09-11 | 73 |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | MQV | 2025-10-13 | 150 |
| K242372 | Mg OSTEOREVIVE, Mg OSTEOCRETE | MQV | 2024-10-18 | 70 |
| K234013 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | MQV | 2024-02-05 | 48 |
| K221256 | Mg OSTEOINJECT | MQV | 2022-06-28 | 57 |
| K212991 | Osteorevive | MQV | 2022-01-21 | 123 |
| K192674 | Mixing and Delivery System | FMF | 2020-02-18 | 145 |
| K161568 | Bone Solutions Mixing and Delivery System | FMF | 2016-09-16 | 101 |
| K071004 | OSTEOCRETE BONE VOID FILLER | MQV | 2009-05-21 | 773 |
Recalls
openFDA lists no recalls under a recalling firm named Bone Solutions, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bone Index Finland , Ltd. (3 510(k)s)
- Bone Anchorage Systems, Inc. (1 510(k)s)
- Bone Health Technologies, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bone Solutions, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Bone Solutions, Inc.” (first 2009, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bone Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bone Solutions, Inc. is 101 days. Since 2017: 73 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bone Solutions, Inc.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 7); FMF (Syringe, Piston, 2).
Next steps
- See all 9 Bone Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Bone Solutions, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.