GlassBone Granules
GlassBone Granules is a synthetic bone substitute for filling skeletal voids or gaps in the extremities and pelvis that do not determine structural stability. It is used for defects caused…
GlassBone Granules is a synthetic bone substitute for filling skeletal voids or gaps in the extremities and pelvis that do not determine structural stability. It is used for defects caused by surgery, trauma or benign bone cysts and tumors in adults and children aged six years or older.
The granules release ions that react with body fluids and alter the glass surface toward a composition resembling natural bone mineral. The material provides an osteoconductive filler that resorbs and is replaced by bone during healing.
Composition and Supply
The 45S5 bioactive glass contains 45% silicon dioxide, 6% phosphorus pentoxide, 24.5% calcium oxide and 24.5% sodium oxide by weight. It is supplied as sterile single use granules in 0.5 to 1 mm or 1 to 3 mm sizes and several fill volumes.
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Allgens Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 1 |
Record
| Listed by | Noraker, France |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Manufacturer |
| 510(k) | K242782 |
| Record published | 2026-05-27 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 25 °C |
| Sizes | Total volume 0.5 to 16 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0.5-1mm; 1cc | Granule size, min: 0.5 mm | In distribution |
| 1-3 mm; 5cc | Granule size, min: 1 mm | In distribution |
| 0.5-1mm; 5cc | Granule size, min: 0.5 mm | In distribution |
| 1-3 mm; 10cc | Granule size, min: 1 mm | In distribution |
| 1-3 mm; 1cc | Granule size, min: 1 mm | In distribution |
| 1-3 mm; 16cc | Granule size, min: 1 mm | In distribution |
| 0.5-1mm; 0.5cc | Granule size, min: 0.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synthacer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 360 |
| Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 357 |
| Biosorb | S.B.M | 65 |
| MagnetOs | Kuros Biosciences B.V | 61 |
| BioSet® | Rti Surgical, Inc. | 47 |
| Bicera® Resorbable Bone Substitute | Wiltrom Corporation Limited | 41 |
| GRAFTON®and Grafton PLUS®Demineralized Bone Matrix (DBM) | Medtronic Sofamor Danek, Inc. | 40 |
| Bicera® Resorbable Bone Substitute | Wiltrom Co., Ltd. (Chutung) | 39 |
| ChronOS | Synthes Gmbh | 39 |
| Synthacer/Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 36 |
| Inion BioRestore™ | Inion OY | 35 |
| Resorba Synthetic Bone | Biomatlante | 35 |
Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242782 | 2024-12-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.