FDA product code MQV: Filler, Bone Void, Calcium Compound
MQV is the FDA product code for filler, bone void, calcium compound. It is a Class II device, regulated under 21 CFR 888.3045 and reviewed by the Orthopedic panel. FDA has cleared 493 510(k) submissions under MQV, 77 in the last five years, from 183 different applicants. The average 510(k) review took 149 days (median 112); 99 days on average over the last three years. FDA has posted 120 recalls for MQV devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Bone Void, Calcium Compound |
| Device class | Class II |
| Regulation | 21 CFR 888.3045 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MQV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 17 | 149 |
| 2018 | 23 | 137 |
| 2019 | 13 | 102 |
| 2020 | 15 | 160 |
| 2021 | 8 | 110 |
| 2022 | 9 | 133 |
| 2023 | 21 | 114 |
| 2024 | 28 | 90 |
| 2025 | 14 | 92 |
| 2026 | 5 | 116 |
Compare with all 510(k) review times · Search every MQV clearance
Top MQV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrightmedicaltechnologyinc | 28 | 2022-01-05 |
| Novabone Products, LLC | 19 | 2024-09-25 |
| Berkeley Advanced Biomaterials, Inc. | 13 | 2012-03-15 |
| Kuros Biosciences B.V | 11 | 2025-05-23 |
| Biocomposites, Ltd. | 11 | 2025-04-07 |
178 more applicants have MQV clearances. See the full list in Caduvo.
Most recent MQV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262230 | Bone Solutions, Inc. | Mg OSTEOREVIVE;Mg OSTEOCRETE | 2026-09-11 | 73 |
| K260364 | Geistlich Pharma AG | Device 300419 Strip | 2026-06-02 | 118 |
| K252797 | Sdip Innovations Pty, Ltd. | JAZBI Resorbable Bone Void Filler | 2026-05-26 | 265 |
| K261008 | Stryker Spine | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute | 2026-04-24 | 29 |
| K253524 | Biomendex OY | Adaptos®Fuse Bone Graft | 2026-02-17 | 96 |
Recalls for MQV devices
120 product recalls in 46 recall events; 12 initiated in the last five years and 12 still open. Most recent: 2026-07-02.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 4 |
| 2020 | 36 |
| 2021 | 1 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code MQV?
MQV is the FDA product code for filler, bone void, calcium compound. It is a Class II device, regulated under 21 CFR 888.3045 and reviewed by the Orthopedic panel.
What device class is MQV?
Class II, regulation 21 CFR 888.3045. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQV?
Across 493 cleared submissions the average was 149 days from receipt to decision (median 112).
Which companies have the most MQV clearances?
Wrightmedicaltechnologyinc (28); Novabone Products, LLC (19); Berkeley Advanced Biomaterials, Inc. (13); Kuros Biosciences B.V (11); Biocomposites, Ltd. (11).
Have MQV devices been recalled?
Yes: 120 product recalls across 46 recall events; the most recent began 2026-07-02.
Next steps
- Run an FDA pathway report with predicate devices for product code MQV
- Run a recall and safety report across every MQV manufacturer
- Watch product code MQV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times