FDA product code MQP: Spinal Vertebral Body Replacement Device
MQP is the FDA product code for spinal vertebral body replacement device. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel. FDA has cleared 279 510(k) submissions under MQP, 9 in the last five years, from 108 different applicants. The average 510(k) review took 114 days (median 88); 148 days on average over the last three years. FDA has posted 46 recalls for MQP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Spinal Vertebral Body Replacement Device |
| Device class | Class II |
| Regulation | 21 CFR 888.3060 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MQP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 154 |
| 2018 | 6 | 166 |
| 2019 | 8 | 116 |
| 2020 | 3 | 98 |
| 2022 | 1 | 472 |
| 2023 | 1 | 77 |
| 2024 | 4 | 208 |
| 2026 | 3 | 88 |
Compare with all 510(k) review times · Search every MQP clearance
Top MQP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Sofamor Danek | 24 | 2017-12-20 |
| Globus Medical, Inc. | 11 | 2019-05-08 |
| Spine Wave, Inc. | 10 | 2015-02-19 |
| Interpore Cross Intl. | 10 | 2005-05-27 |
| Signus Medizintechnik GmbH | 8 | 2014-01-14 |
103 more applicants have MQP clearances. See the full list in Caduvo.
Most recent MQP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261810 | Foundation Surgical Group | Vertiwedge® Intraosseous System | 2026-07-31 | 60 |
| K261031 | Signus Medinzintechnik GmbH | POSEIDON ST | 2026-07-10 | 102 |
| K253158 | Vy Spine, LLC | VyBrate VBR System | 2026-01-07 | 103 |
| K241468 | Foundation Surgical Group, Inc. | Vertiwedge® Intraosseous System | 2024-11-07 | 167 |
| K232790 | Icotec AG | KONG®-TL VBR System and KONG® C VBR System | 2024-04-04 | 206 |
Recalls for MQP devices
46 product recalls in 19 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-10.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 15 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code MQP?
MQP is the FDA product code for spinal vertebral body replacement device. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel.
What device class is MQP?
Class II, regulation 21 CFR 888.3060. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQP?
Across 279 cleared submissions the average was 114 days from receipt to decision (median 88).
Which companies have the most MQP clearances?
Medtronic Sofamor Danek (24); Globus Medical, Inc. (11); Spine Wave, Inc. (10); Interpore Cross Intl. (10); Signus Medizintechnik GmbH (8).
Have MQP devices been recalled?
Yes: 46 product recalls across 19 recall events; the most recent began 2022-11-10.
Next steps
- Run an FDA pathway report with predicate devices for product code MQP
- Run a recall and safety report across every MQP manufacturer
- Watch product code MQP 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.
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