Atlas FDA

MQV

492 FDA 510(k) clearances · Product code

112 daysmedian time to decision
283 days90th percentile
492clearances measured

FDA profile

Official device name
Filler, Bone Void, Calcium Compound
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3045
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 101 · 2022: 47 · 2023: 120 · 2024: 68 · 2025: 58 · 2026: 49
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Device 300419 Strip (K260364)Geistlich Pharma AG2026-06-02
JAZBI™ Resorbable Bone Void Filler (K252797)Sdip Innovations Pty, Ltd.2026-05-26
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 (K261008)Stryker Spine2026-04-24
Adaptos®Fuse Bone Graft (K253524)Biomendex OY2026-02-17
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 (K253147)Prosidyan, Inc.2025-10-22
Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (K251522)Bone Solutions, Inc.2025-10-13
Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) (K252085)Wright Medical Technology, Inc. (Stryker Corporation)2025-09-30
Device 300423 Granules (K251556)Geistlich Pharma AG2025-07-17
OsteoFlo HydroFiber (K251720)SurGenTec, LLC2025-07-02
Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (K251193)Medtronic Sofamor Danek, Inc.2025-06-12
OsteoFlo HydroFiber (K243949)SurGenTec, LLC2025-05-28
MagnetOs MIS (K243474)Kuros Biosciences B.V2025-05-23
Synthecure Synthetic Calcium Sulfate (K250141)Austin Medical Ventures, Inc.2025-05-16
NanoBone® SBX Putty ; NanoBone® QD (K250521)Biocomposites, Ltd.2025-04-07
Porous Biologic Scaffold (K250556)Ventris Medical2025-03-21
BonVie+ (K250346)Elute, Inc.2025-02-26
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (K241555)Rti Surgical, Inc.2025-02-21
Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (K243706)Medtronic Sofamor Danek, Inc.2025-01-17
GlassBone Granules (K242782)Noraker2024-12-23
OsteoFlo HydroFiber (K242797)SurGenTec, LLC2024-12-23
BioSphere Putty; BioSphere MIS Putty (K241167)Synergy Biomedical2024-12-20
EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) (K243609)Etex Corporation2024-12-18
Porous Biologic Scaffold (K240765)Ventris Medical2024-12-18
MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (K243526)Orthocon, Inc.2024-12-05
Montage-XT Settable Bone Putty (K243506)Orthocon, Inc.2024-11-18
Device 300397 Putty (K241802)Geistlich Pharma AG2024-11-08
Citrepore™ (K240450)Acuitive Technologies, Inc.2024-11-06
Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (K242372)Bone Solutions, Inc.2024-10-18
Cove Putty, OsteoCove Putty (K242273)SeaSpine Orthopedics Corporation2024-09-25
NovaBone Putty - Synthetic Bioactive Bone Graft (K242299)Novabone Products, LLC2024-09-25
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 Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips (K242280)Stryker Spine2024-08-29
Montage-XT Settable, Resorbable Bone Putty (K233566)Orthocon, Inc.2024-08-21
Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (K241564)Baxter Healthcare Corporation2024-08-02
Montage Settable Bone Putty (K242050)Orthocon, Inc.2024-07-29
MagnetOs Easypack Putty (K241212)Kuros Biosciences2024-06-27
Xerosyn (K233259)Xerothera, Inc.2024-06-21
Morpheus® Moldable; Agilon® Moldable (K240621)Biogennix, LLC2024-04-30
MagnetOs Putty (K240442)Kuros Biosciences B.V2024-04-01
NuVasive AttraX Scaffold (K240507)Nuvasive, Inc.2024-03-20
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (K240424)Collagen Matrix, Inc.2024-03-12
Synthetic Bone Putty (K240458)Ventris Medical2024-03-07
Cerament Bone Void Filler (K240459)Bonesupport AB2024-03-05
NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) (K240404)Novabone Products, LLC2024-03-05
ReBOSSIS (K240453)Orthorebirth Co., Ltd.2024-03-04
Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (K234013)Bone Solutions, Inc.2024-02-05
MagnetOs Granules (K232347)Kuros Biosciences B.V2024-01-19
MagnetOs Putty (K230736)Kuros Biosciences B.V2023-12-20
Tactoset® Injectable Bone Substitute (K231968)Anika Therapeutics, Inc.2023-12-20
MagnetOs Easypack Putty (K233607)Kuros Biosciences B.V2023-12-15
SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (K233490)Bioventus, LLC2023-12-05
MagnetOs Flex Matrix (K233245)Kuros Biosciences B.V2023-11-21
OsteoFlo® HydroPutty™ (K231716)SurGenTec, LLC2023-10-02
Cove Strip, OsteoCove Strip (K232668)SeaSpine Orthopedics Corporation2023-09-27
Catalyst Bone Void Filler (K232315)Ossdsign AB2023-09-15
Cove Putty, OsteoCove Putty (K231030)SeaSpine Orthopedics Corporation2023-09-14
Montage Flowable Settable, Resorbable Bone Paste (K231270)Orthocon, Inc.2023-09-01
Montage-QS Settable, Resorbable Bone Putty (K231903)Orthocon, Inc.2023-08-25
Cove Strip (K230486)SeaSpine Orthopedics Corporation2023-08-21
Mineral Collagen Composite Bioactive Extra Moldable (K231942)Collagen Matrix, Inc.2023-08-02
Graftys Quickset (K231714)Graftys2023-07-12
Bonalive Orthopedics granules (K231528)Bonalive Biomaterials, Ltd.2023-07-11
Tactoset (K223915)Anika Therapeutics, Inc.2023-03-29
DSM Biomedical Calcium Phosphate Cement (K230054)Dsm Biomedical2023-03-21
GaiaBone Bioabsorbable Bone Graft (K220337)Corliber (Shenzhen) Medical Device Co., Ltd.2023-02-03
MONTAGE Settable, Resorbable Bone Putty (K222063)Orthocon, Inc.2023-02-03
OsteoCNX (K223563)Converg Engineering2023-01-25
Uni-FuZe-C Bone Strip (K221726)Zavation Medical Products, LLC2023-01-18
Mineral Collagen Composite Bioactive Moldable (K221735)Collagen Matrix, Inc.2022-12-20
Synthetic Bone Putty (K221644)Ventris Medical2022-09-02
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute (K213803)Prosidyan, Inc.2022-08-23
Mg OSTEOINJECT (K221256)Bone Solutions, Inc.2022-06-28
MagnetOs Flex Matrix (K213959)Kuros Biosciences B.V2022-04-14
Genex Bone Graft Substitute (K212721)Biocomposites, Ltd.2022-02-04
Osteorevive (K212991)Bone Solutions, Inc.2022-01-21
MagnetOs granules (K213111)Kuros Biosciences B.V2022-01-10
PRO-DENSE LoVisc Bone Graft Substitute (K213342)Wrightmedicaltechnologyinc2022-01-05
ABCcolla Bone Matrix (K212156)Acro Biomedical Co., Ltd.2021-10-08
Dry DBM- A Putty (K212135)Seaspine Corporation2021-10-04
DB-EZ Bone Void Filler (K212353)Dimensional Bioceramics, LLC2021-09-22
MagnetOs Easypack Putty (K211201)Kuros Biosciences B.V2021-09-02
Tactoset Injectable Bone Substitute (K212083)Anika Therapeutics, Inc.2021-08-31
CaP Spheres Pellet Pack (K203218)Zimmer Biomet Spine, Inc.2021-05-04
si-Mochi (K202639)Biostone, Ltd.2021-04-21
DB-Composite (K210193)Dimensional Bioceramics, LLC2021-03-15
Uni-FuZe-P Bone Putty (K201781)Zavation Medical Products, LLC2020-12-28
PRO-DENSE LoVisc Bone Graft Substitute (K200507)Wrightmedicaltechnologyinc2020-10-21
Cerament Bone Void Filler (K201535)Bonesupport AB2020-10-16
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft (K200064)SurGenTec, LLC2020-08-14
CureOs TCP (K191670)Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic2020-08-04
Altapore MIS (K201464)Baxter Healthcare Corporation2020-06-30
SIGNAFUSE Bioactive Bone Graft (K193513)Bioventus2020-06-18
Osteo3 ZP Putty (K193075)Sirakoss , Ltd.2020-06-09
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) (K200290)SeaSpine Orthopedics Corporation2020-05-11
ALTAPORE SHAPE (K200640)Baxter Healthcare Corporation2020-05-08
DB-Orthopedics (K200752)Dimensional Bioceramics, LLC2020-04-22
Agilon Strip (K193487)Biogennix, LLC2020-03-30
Agilon Moldable (K193168)Biogennix, LLC2020-02-13
SCS 17-01 (K190956)Anika Therapeutics, Inc.2020-01-30
Altapore (K192363)Baxter Healthcare Corporation2020-01-09
Resorbable Mesh Device (K193040)SeaSpine Orthopedics Corporation2019-11-30
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Every clearance here is in the API, with alerts when new ones post.