FDA product code · Orthopedic · Class 2
MQV: Filler, Bone Void, Calcium Compound
MQV is FDA's product code for "Filler, Bone Void, Calcium Compound": a Class 2 device classified under 21 CFR 888.3045, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for MQV
Across 136 510(k) clearances under MQV decided from 2018-01-01 to 2026-10-06, the median was 90 days from FDA receipt to decision. Half took between 49 and 169 days, and 80% were decided within 183 days. These are past clearances, not a forecast for a new submission.
| Fastest | 6 |
|---|---|
| 25th percentile | 49 |
| Median | 90 |
| 75th percentile | 169 |
| 80th percentile | 183 |
| 90th percentile | 252 |
| Slowest | 410 |
| Year | Median days | n |
|---|---|---|
| 2018 | 124 | 23 |
| 2019 | 90 | 13 |
| 2020 | 132 | 15 |
| 2021 | 88 | 8 |
| 2022 | 118 | 9 |
| 2023 | 74 | 21 |
| 2024 | 55 | 28 |
| 2025 | 57 | 14 |
| 2026 (to 10-06, partial) | 96 | 5 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MQV in the public FDA record
| 510(k) clearances, all years | 492 |
|---|---|
| Device recalls | 120 |
| Establishment listings | 882 |
| GUDID device identifiers | 4,678 |
Counts of records, not of devices or events. Adverse event reports for MQV are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MQV
14 FDA recognized consensus standards cite MQV, 1 of them recognized only in part, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F983-24. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 15-44 ASTM F2529-13 (partial recognition) — Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
- 15-54 ASTM F3207-17 — Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
- 8-427 ASTM F1185-03 (Reapproved 2014) — Standard Specification for Composition of Hydroxylapatite for Surgical Implants
- 8-429 ASTM F2224-09 (Reapproved 2020) — Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
- 8-457 ISO 13175-3 First edition 2012-10-01 — Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
- 8-491 ASTM F1088-18 — Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
- 8-493 ISO 13779-2 Third edition 2018-12 — Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
- 8-516 ISO 13779-4 Second edition 2018-12 — Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
- 8-579 ISO 13779-3 Second Edition 2018-12 — Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
- 8-593 ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 — Implants for surgery - Hydroxyapatite - Part 6: Powders
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.