MQVFDA Class 2 · 21 CFR 888.3045 · implantable
Filler, Bone Void, Calcium Compound
Device family · Orthopedic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
490
Manufacturers
71
Flagged signals
14
Adverse-event reports
1,659
Code matrix
| FDA product code | MQV |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2014 | 5 | 415.7 | 1,677 |
| Other | 2011 | 6 | 399.0 | 2,003 |
| Other | 2010 | 4 | 241.8 | 735 |
| Other | 2012 | 3 | 199.5 | 411 |
| Other | 2011 | 3 | 181.4 | 373 |
| Other | 2013 | 7 | 122.5 | 727 |
| Other | 2011 | 3 | 55.4 | 111 |
| Death | 2019 | 4 | 41.3 | 121 |
| Death | 2019 | 4 | 16.8 | 45 |
| Other | 2014 | 4 | 15.3 | 40 |
| Other | 2013 | 4 | 15.3 | 40 |
| Other | 2012 | 4 | 15.3 | 40 |
| Injury | 2022 | 4 | 2.6 | 4 |
| Injury | 2025 | 4 | 2.6 | 4 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 1,659 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Wrightmedicaltechnologyinc | 28 | 2022 | — |
| NOVABONE PRODUCTS, LLC | 19 | 2024 | — |
| Prosidyan, Inc. | 10 | 2025 | — |
| Synthes (Usa) | 8 | 2007 | — |
| Baxter Healthcare Corporation | 7 | 2024 | — |
| Seaspine Orthopedics Corporation | 7 | 2024 | — |
| COLLAGEN MATRIX, INC. | 7 | 2024 | — |
| GLOBUS MEDICAL, INC. | 7 | 2014 | — |
| Biogennix, LLC | 6 | 2024 | — |
| Skeletal Kinetics, Llc | 6 | 2014 | — |
| curasan AG | 6 | 2018 | — |
| BONE SOLUTIONS, INC. | 6 | 2025 | — |
| MEDTRONIC SOFAMOR DANEK, INC. | 6 | 2025 | — |
| SURGENTEC, LLC | 5 | 2025 | — |
| Pioneer Surgical Technology | 5 | 2011 | — |
| BONESUPPORT AB | 5 | 2024 | — |
| Medtronic Sofamor Danek USA, Inc. | 5 | 2015 | — |
| Interpore Cross Intl. | 5 | 2005 | — |
| BIOMATLANTE | 5 | 2007 | — |
| Medtronic Sofamor Danek | 5 | 2009 | — |
| Anika Therapeutics, Inc. | 5 | 2023 | — |
| Smith & Nephew, Inc. | 4 | 2007 | — |
| ISOTIS ORTHOBIOLOGICS, INC. | 4 | 2007 | — |
| BIOSTRUCTURES, LLC | 4 | 2016 | — |
| GRAFTYS | 4 | 2023 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
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 Spine510(k) · 2026-04-24
Adaptos®Fuse Bone Graft · Biomendex OY510(k) · 2026-02-17
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.510(k) · 2025-10-22
Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE · Bone Solutions, Inc.510(k) · 2025-10-13
Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) · Wright Medical Technology, Inc. (Stryker Corporation)510(k) · 2025-09-30
Device 300423 Granules · Geistlich Pharma AG510(k) · 2025-07-17
OsteoFlo HydroFiber · SurGenTec, LLC510(k) · 2025-07-02
Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft · Medtronic Sofamor Danek, Inc.510(k) · 2025-06-12
OsteoFlo HydroFiber · SurGenTec, LLC510(k) · 2025-05-28
MagnetOs MIS · Kuros Biosciences B.V510(k) · 2025-05-23
Synthecure Synthetic Calcium Sulfate · Austin Medical Ventures, Inc.510(k) · 2025-05-16
NanoBone® SBX Putty ; NanoBone® QD · Biocomposites, Ltd.510(k) · 2025-04-07
Porous Biologic Scaffold · Ventris Medical510(k) · 2025-03-21
BonVie+ · Elute, Inc.510(k) · 2025-02-26
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC · Rti Surgical, Inc.510(k) · 2025-02-21
Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules · Medtronic Sofamor Danek, Inc.510(k) · 2025-01-17
GlassBone Granules · Noraker510(k) · 2024-12-23
OsteoFlo HydroFiber · SurGenTec, LLC510(k) · 2024-12-23
BioSphere Putty; BioSphere MIS Putty · Synergy Biomedical510(k) · 2024-12-20
EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) · Etex Corporation510(k) · 2024-12-18
Porous Biologic Scaffold · Ventris Medical510(k) · 2024-12-18
MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty · Orthocon, Inc.510(k) · 2024-12-05
Montage-XT Settable Bone Putty · Orthocon, Inc.510(k) · 2024-11-18
Device 300397 Putty · Geistlich Pharma AG510(k) · 2024-11-08
Citrepore · Acuitive Technologies, Inc.510(k) · 2024-11-06
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.