Adaptos®Fuse Bone Graft
FDA 510(k) K253524 · Biomendex OY
510(k) numberK253524
Submission
- Device name
- Adaptos®Fuse Bone Graft
- Applicant
- Biomendex OY
Tampere, FI - Received
- November 13, 2025
- Decision date
- February 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone GraftMQV · Traditional | Medtronic Sofamor Danek, Inc. | 06/12/2025SE |
Questions and answers
When was Adaptos®Fuse Bone Graft cleared by the FDA?
Adaptos®Fuse Bone Graft (K253524) received a 510(k) decision of Substantially Equivalent on February 17, 2026, 96 days after the submission was received.
What is the product code of K253524?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.