FDA product code · Orthopedic
MQPSpinal Vertebral Body Replacement Device
Product code MQP covers Spinal Vertebral Body Replacement Device, a Class II device regulated under 21 CFR 888.3060. FDA has cleared 278 devices in this code, 2 of them in the last 12 months. Median review time across the 278 most recent decisions is 88 days. openFDA lists 46 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3060
- Review panel
- Orthopedic
- Clearances
- 278
What is happening in MQP right now?
MQP (Spinal Vertebral Body Replacement Device) has three findings, most consequential first. Adverse events reported in 2026-03 ran high — 32 reports against an expected 0 to 28 (MQP:MAUDE:2026-03). 2 first-time filers in the last 12 months, Signus Medinzintechnik GmbH and Vy Spine, LLC (K261031, K253158). The code is crowded, scoring 71 of 100 — 98 companies hold a clearance here and 2 arrived in the last 12 months (MQP:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Adverse-event spike | Serious | MQP:MAUDE:2026-03 |
| New entrant | Worth knowing | K261031, K253158 |
| Crowding | Context | MQP:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in MQP?
FDA has cleared 278 devices under product code MQP since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261031 | POSEIDON ST | Signus Medinzintechnik GmbH | |
| K253158 | VyBrate VBR System | Vy Spine, LLC | |
| K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | |
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | |
| K202637 | F3D Corpectomy System | Corelink, LLC | |
| K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG |
How long does FDA review take for MQP?
The median FDA review time for MQP is 88 days, measured across the 278 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MQP?
openFDA lists 46 recall records against product code MQP. A recall record covers one firm's corrective action and may span many device lots.
Z-0738-2023Open, ClassifiedNuVasive Inc
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
Z-0403-2021TerminatedSynthes (USA) Products LLC
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0404-2021TerminatedSynthes (USA) Products LLC
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0405-2021TerminatedSynthes (USA) Products LLC
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0406-2021TerminatedSynthes (USA) Products LLC
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Showing the 5 most recently initiated of 46. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MQP?
MAUDE holds 362 adverse-event reports naming product code MQP, 108 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MQP unusual?
2 months sit above MQP's own expected range: 1 January 2025, 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 7 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 22 | 0–18 | Above expected (0–18) | |
| 8 | 0–22 | Within expected (0–22) | |
| 23 | 0–24 | Within expected (0–24) | |
| 5 | 2–28 | Within expected (2–28) | |
| 21 | 0–24 | Within expected (0–24) | |
| 14 | 0–29 | Within expected (0–29) | |
| 7 | 0–45 | Within expected (0–45) | |
| 8 | 0–31 | Within expected (0–31) | |
| 16 | 0–31 | Within expected (0–31) | |
| 11 | 0–31 | Within expected (0–31) | |
| 14 | 0–27 | Within expected (0–27) | |
| 10 | 0–30 | Within expected (0–30) | |
| 8 | 0–34 | Within expected (0–34) | |
| 10 | 0–26 | Within expected (0–26) | |
| 32 | 0–28 | Above expected (0–28) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in MQP.
Who has entered MQP in the last year?
2 companies filed in MQP for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Signus Medinzintechnik GmbH | K261031 | |
| Vy Spine, LLC | K253158 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in MQP?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MQP?
Across the 278 most recent decisions, these applicants filed most often in MQP.
| Applicant | Recent clearances |
|---|---|
| Medtronic Sofamor Danek | 24 |
| Globus Medical, Inc. | 11 |
| Interpore Cross Intl. | 10 |
| Spine Wave, Inc. | 10 |
| Depuyacromed | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in MQP files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Medtronic Sofamor Danek, Inc. | 30 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MQP
Get an email the morning anything changes in MQP — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.