Adaptos®Fuse Bone Graft— 510(k) K253524
Substantially EquivalentBiomendex OY
FDA 510(k) clearance K253524 for Adaptos®Fuse Bone Graft, Substantially Equivalent on 2026-02-17. Applicant: Biomendex OY. Device class: 2.
Summary
Biomendex's Adaptos®Fuse Bone Graft is filed under product code MQV, calcium compound bone void filler. The record doesn't describe the graft beyond its name and that code name.
Class II, 21 CFR 888.3045. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Biomendex filed from Tampere, Finland. The substantially equivalent decision came 96 calendar days after receipt (November 13, 2025 to February 17, 2026).
Clearance details
- Applicant
- Biomendex OY
- Product code
- Product code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampere, FI
Recent devices under product code MQV
view all- K262230 — Mg OSTEOREVIVE; Mg OSTEOCRETE
- K260364 — Device 300419 Strip
- K252797 — JAZBI Resorbable Bone Void Filler
- K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more
- 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
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.