MQV · Filler, Bone Void, Calcium Compound
Orthopedic · 21 CFR 888.3045 · Class 2
Overview
| Product Code | MQV |
|---|---|
| Device Name | Filler, Bone Void, Calcium Compound |
| Regulation | 21 CFR 888.3045 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
Recent Cleared Devices (20 of 491)
Showing 20 most recent of 491 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252797 | JAZBI™ Resorbable Bone Void Filler | Sdip Innovations Pty, Ltd. | May 26, 2026 | SESE |
| 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 | Apr 24, 2026 | SESE |
| K253524 | Adaptos®Fuse Bone Graft | Biomendex OY | Feb 17, 2026 | SESE |
| 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. | Oct 22, 2025 | SESE |
| K251522 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | Bone Solutions, Inc. | Oct 13, 2025 | SESE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) | Sep 30, 2025 | SESE |
| K251556 | Device 300423 Granules | Geistlich Pharma AG | Jul 17, 2025 | SESE |
| K251720 | OsteoFlo HydroFiber | SurGenTec, LLC | Jul 2, 2025 | SESE |
| K251193 | Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft | Medtronic Sofamor Danek, Inc. | Jun 12, 2025 | SESE |
| K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | May 28, 2025 | SESE |
| K243474 | MagnetOs MIS | Kuros Biosciences B.V | May 23, 2025 | SESE |
| K250141 | Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. | May 16, 2025 | SESE |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. | Apr 7, 2025 | SESE |
| K250556 | Porous Biologic Scaffold | Ventris Medical | Mar 21, 2025 | SESE |
| K250346 | BonVie+ | Elute, Inc. | Feb 26, 2025 | SESE |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. | Feb 21, 2025 | SESE |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Medtronic Sofamor Danek, Inc. | Jan 17, 2025 | SESE |
| K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | Dec 23, 2024 | SESE |
| K242782 | GlassBone Granules | Noraker | Dec 23, 2024 | SESE |
| K241167 | BioSphere Putty; BioSphere MIS Putty | Synergy Biomedical | Dec 20, 2024 | SESE |
Top Applicants
- Wrightmedicaltechnologyinc — 28 clearances
- Novabone Products, LLC — 19 clearances
- Berkeley Advanced Biomaterials, Inc. — 13 clearances
- Biocomposites, Ltd. — 11 clearances
- Etex Corp. — 11 clearances
