BonAlive Granules
by Bonalive Biomaterials, Ltd. Finland 510(k)
510(k) K191274 Product code MQV
Overview
BonAlive Granules are sterile medical granules composed of S53P4 bioactive glass, a synthetic osteoconductive material containing silicon dioxide, sodium oxide, calcium oxide and phosphorus pentoxide. The bioactive glass is designed to attach to living tissue, facilitate bone tissue growth, and chemically bond with surrounding bone, thereby supporting bone regeneration.
The granules are supplied in two size ranges (0.5‑0.8 mm or 1.0‑2.0 mm) as a sterile device. They are cleared under FDA 510(k) (K191274) with a substantially equivalent decision (product code MQV) and are intended for orthopedic use. The device is provided by Bonalive Biomaterials Ltd. and is packaged for sterile, single‑use application.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191274 | Date7 Aug 2019 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQV
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bonalive Biomaterials, Ltd.
Questions
What clinical purpose do BonAlive Granules serve?
They are intended for orthopedic use to support bone regeneration. The S53P4 bioactive glass attaches to living tissue, promotes new bone growth, and chemically bonds with surrounding bone, helping to fill defects or augment fixation in surgical procedures.
In what sizes and packaging are the granules provided?
BonAlive Granules are offered in two sterile size ranges: 0.5‑0.8 mm and 1.0‑2.0 mm. Each size is packaged for single‑use application, ensuring sterility and eliminating the need for re‑processing between cases.
Is the product reusable or single‑use only?
The granules are supplied as a sterile, single‑use device. This design prevents cross‑contamination and maintains the material’s bioactive properties, which could be compromised by re‑sterilization or reuse.
What regulatory pathway was used for market clearance?
BonAlive Granules received clearance through the FDA 510(k) pathway (K191274) with a substantially equivalent decision under product code MQV. This indicates the device was found to be comparable to a legally marketed predicate for orthopedic applications.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K191274