Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MQV — Predicate Candidate Screening
492 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
283 days90th percentile
492clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260364 | Device 300419 Strip | Geistlich Pharma AG | 2026-06-02 | 118 | 0 |
| K252797 | JAZBI™ Resorbable Bone Void Filler | Sdip Innovations Pty, Ltd. | 2026-05-26 | 265 | 0 |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; | Stryker Spine | 2026-04-24 | 29 | 0 |
| K253524 | Adaptos®Fuse Bone Graft | Biomendex OY | 2026-02-17 | 96 | 0 |
| K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ B | Prosidyan, Inc. | 2025-10-22 | 27 | 0 |
| K251522 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2025-10-13 | 150 | 0 |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allom | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-09-30 | 90 | 0 |
| K251556 | Device 300423 Granules | Geistlich Pharma AG | 2025-07-17 | 57 | 0 |
| K251720 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025-07-02 | 28 | 0 |
| K251193 | Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft | Medtronic Sofamor Danek, Inc. | 2025-06-12 | 56 | 0 |
| K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025-05-28 | 156 | 0 |
| K243474 | MagnetOs MIS | Kuros Biosciences B.V | 2025-05-23 | 196 | 0 |
| K250141 | Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. | 2025-05-16 | 119 | 0 |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. | 2025-04-07 | 45 | 0 |
| K250556 | Porous Biologic Scaffold | Ventris Medical | 2025-03-21 | 24 | 0 |
| K250346 | BonVie+ | Elute, Inc. | 2025-02-26 | 20 | 0 |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CC | Rti Surgical, Inc. | 2025-02-21 | 266 | 0 |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty | Medtronic Sofamor Danek, Inc. | 2025-01-17 | 49 | 0 |
| K242782 | GlassBone Granules | Noraker | 2024-12-23 | 98 | 0 |
| K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024-12-23 | 98 | 0 |
| K241167 | BioSphere Putty; BioSphere MIS Putty | Synergy Biomedical | 2024-12-20 | 238 | 0 |
| K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone | Etex Corporation | 2024-12-18 | 26 | 0 |
| K240765 | Porous Biologic Scaffold | Ventris Medical | 2024-12-18 | 273 | 0 |
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, | Orthocon, Inc. | 2024-12-05 | 21 | 0 |
| K243506 | Montage-XT Settable Bone Putty | Orthocon, Inc. | 2024-11-18 | 6 | 0 |
| K241802 | Device 300397 Putty | Geistlich Pharma AG | 2024-11-08 | 140 | 0 |
| K240450 | Citrepore™ | Acuitive Technologies, Inc. | 2024-11-06 | 265 | 0 |
| K242372 | Mg OSTEOREVIVE™, Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2024-10-18 | 70 | 0 |
| K242273 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | 2024-09-25 | 55 | 2 |
| K242299 | NovaBone Putty - Synthetic Bioactive Bone Graft | Novabone Products, LLC | 2024-09-25 | 54 | 0 |
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, | Stryker Spine | 2024-08-29 | 27 | 0 |
| K233566 | Montage-XT Settable, Resorbable Bone Putty | Orthocon, Inc. | 2024-08-21 | 289 | 0 |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPO | Baxter Healthcare Corporation | 2024-08-02 | 63 | 0 |
| K242050 | Montage Settable Bone Putty | Orthocon, Inc. | 2024-07-29 | 17 | 0 |
| K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024-06-27 | 58 | 0 |
| K233259 | Xerosyn | Xerothera, Inc. | 2024-06-21 | 266 | 0 |
| K240621 | Morpheus® Moldable; Agilon® Moldable | Biogennix, LLC | 2024-04-30 | 56 | 0 |
| K240442 | MagnetOs Putty | Kuros Biosciences B.V | 2024-04-01 | 47 | 0 |
| K240507 | NuVasive AttraX Scaffold | Nuvasive, Inc. | 2024-03-20 | 28 | 0 |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Mat | Collagen Matrix, Inc. | 2024-03-12 | 28 | 0 |
| K240458 | Synthetic Bone Putty | Ventris Medical | 2024-03-07 | 20 | 0 |
| K240459 | Cerament Bone Void Filler | Bonesupport AB | 2024-03-05 | 18 | 0 |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6 | Novabone Products, LLC | 2024-03-05 | 25 | 0 |
| K240453 | ReBOSSIS | Orthorebirth Co., Ltd. | 2024-03-04 | 18 | 2 |
| K234013 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2024-02-05 | 48 | 0 |
| K232347 | MagnetOs Granules | Kuros Biosciences B.V | 2024-01-19 | 168 | 0 |
| K230736 | MagnetOs Putty | Kuros Biosciences B.V | 2023-12-20 | 278 | 0 |
| K231968 | Tactoset® Injectable Bone Substitute | Anika Therapeutics, Inc. | 2023-12-20 | 170 | 0 |
| K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023-12-15 | 36 | 0 |
| K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty | Bioventus, LLC | 2023-12-05 | 39 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda