FDA product code · Orthopedic
MQVFiller, Bone Void, Calcium Compound
Product code MQV covers Filler, Bone Void, Calcium Compound, a Class II device regulated under 21 CFR 888.3045. FDA has cleared 492 devices in this code, 7 of them in the last 12 months. Median review time across the 492 most recent decisions is 112 days. openFDA lists 120 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3045
- Review panel
- Orthopedic
- Clearances
- 492
What is happening in MQV right now?
MQV (Filler, Bone Void, Calcium Compound) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2820-2026, Z-2131-2026, Z-2132-2026, Z-1897-2026, Z-0540-2026). 3 first-time filers in the last 12 months, including Sdip Innovations Pty, Ltd. and Biomendex OY (K252797, K253524, K252085). The code is crowded, scoring 87 of 100 — 164 companies hold a clearance here and 7 arrived in the last 12 months (MQV:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2820-2026, Z-2131-2026, Z-2132-2026, Z-1897-2026, Z-0540-2026 |
| New entrant | Worth knowing | K252797, K253524, K252085 |
| Crowding | Context | MQV: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 MQV?
FDA has cleared 492 devices under product code MQV since the 510(k) programme began in 1976, 7 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260364 | Device 300419 Strip | Geistlich Pharma AG | |
| K252797 | JAZBI Resorbable Bone Void Filler | Sdip Innovations Pty, Ltd. | |
| K261008 | 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 | Stryker Spine | |
| K253524 | Adaptos®Fuse Bone Graft | Biomendex OY | |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | Bone Solutions, Inc. | |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) | |
| K251556 | Device 300423 Granules | Geistlich Pharma AG | |
| K251720 | OsteoFlo HydroFiber | SurGenTec, LLC | |
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft | Medtronic Sofamor Danek, Inc. |
How long does FDA review take for MQV?
The median FDA review time for MQV is 112 days, measured across the 492 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 MQV?
openFDA lists 120 recall records against product code MQV. A recall record covers one firm's corrective action and may span many device lots.
Z-2820-2026Open, ClassifiedIsoTis OrthoBiologics, Inc.
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
Z-2131-2026Open, ClassifiedOrthorebirth Co Ltd
Resorbable bone void filler falls outside standard specifications.
Z-2132-2026Open, ClassifiedOrthorebirth Co Ltd
Resorbable bone void filler falls outside standard specifications.
Z-1897-2026Open, ClassifiedXtant Medical Holdings, Inc.
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Z-0540-2026Open, ClassifiedBerkeley Advanced Biomaterials, LLC
Due to incorrect product label (Incorrect product name identified on outer packaging).
Showing the 5 most recently initiated of 120. 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 MQV?
MAUDE holds 213 adverse-event reports naming product code MQV, 41 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 MQV unusual?
Every month with enough history behind it falls inside MQV's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 4 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 9 | 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 | |
| 6 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | 0–10 | Within expected (0–10) | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | 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 | |
| 13 | Insufficient history | No expected range — too little history | |
| 4 | 0–18 | Within expected (0–18) |
33 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 MQV.
Who has entered MQV in the last year?
3 companies filed in MQV for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Sdip Innovations Pty, Ltd. | K252797 | |
| Biomendex OY | K253524 | |
| Wright Medical Technology, Inc. (Stryker Corporation) | K252085 |
"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 MQV?
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 MQV?
Across the 492 most recent decisions, these applicants filed most often in MQV.
| Applicant | Recent clearances |
|---|---|
| Wrightmedicaltechnologyinc | 28 |
| Novabone Products, LLC | 19 |
| Berkeley Advanced Biomaterials, Inc. | 13 |
| Biocomposites, Ltd. | 11 |
| Etex Corp. | 11 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in MQV file 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 |
|---|---|---|
| Berkeley Advanced Biomaterials, LLC | 14 | 2 |
| Etex Corporation | 14 | 2 |
| Orthovita, Inc., dBA Stryker Orthobiologics. | 12 | 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 MQV
Get an email the morning anything changes in MQV — 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.