Bi-Ostetic Bioactive Glass Foam
Bi-Ostetic Bioactive Glass Foam is a resorbable bone void filler that combines a bovine collagen matrix with hydroxyapatite, tricalcium phosphate and 45S5 bioactive glass granules. It is…
Bi-Ostetic Bioactive Glass Foam is a resorbable bone void filler that combines a bovine collagen matrix with hydroxyapatite, tricalcium phosphate and 45S5 bioactive glass granules. It is supplied in granule, strip and putty forms.
The material provides a scaffold for bone growth in gaps that do not determine the structural stability of the bone. Surface reactions on the glass form a calcium phosphate layer, while the graft material is gradually absorbed and remodeled during healing.
Listed Item
Bi-Ostetic™ Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) → tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible. The 45S5 glass particles are bioactive. The device is available in the form of granules, strips, and putty. The composition of the granules is 60 wt% HA and 40 wt% TCP. The amount of 45S5 granules in the graft is 20 wt%. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer on the 45S5 granules and hydroxyapatite-tri-calcium phosphate granules provide an osteoconductive scaffold onto which the patient’s new bone will grow. During healing, the graft particulate is absorbed and remodeled into new bone.
Composition and Preparation
The HA-TCP granules contain 60 percent hydroxyapatite and 40 percent tricalcium phosphate by weight. Bioactive glass granules account for 20 percent of the graft. Preparation depends on the application: posterolateral spine use requires bone marrow aspirate and autograft, while extremity granules and strips may be hydrated with sterile water and blood.
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 | Berkeley Advanced Biomaterials, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Manufacturer |
| 510(k) | K170917 |
| Record published | 2020-08-25 |
| Record revised | 2020-06-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AA-10P | In distribution | |
| AA2-50X10-02 | In distribution | |
| AA1-100X25-12 | In distribution | |
| AA1-8D40-01 | In distribution | |
| AA-06P | In distribution | |
| AA1-50X10-02 | In distribution | |
| AA-02P | In distribution | |
| AA1-5D40-01 | In distribution | |
| AA1-7D40-01 | In distribution | |
| AA-01P | In distribution | |
| AA1-100X25-10 | In distribution | |
| AA-12P | In distribution | |
| AA-05P | In distribution | |
| AA1-6D40-01 | In distribution | |
| AA1-50X25-06 | In distribution | |
| AA1-100X25-15 | In distribution | |
| AA2-50X10-05 | In distribution | |
| AA1-50X10-01 | 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 |
|---|---|
| K170917 | 2017-10-30 |
| K113791 | 2012-03-15 |
| K091912 | 2010-06-23 |
| K092046 | 2010-03-24 |
| K053213 | 2006-07-06 |
| K051914 | 2005-11-03 |
| K051695 | 2005-07-19 |
| K050666 | 2005-04-11 |
| K042636 | 2004-12-14 |
| K041889 | 2004-08-19 |
| K040405 | 2004-03-05 |
| K030266 | 2003-02-20 |
| K023703 | 2003-01-30 |
| K022622 | 2003-01-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Berkeley Advanced Biomaterials | 510(k) number | 2025-09-02 | Class II | Process control | Due to incorrect product label (Incorrect product name identified on outer packaging). | 62 units |
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.