BioSphere Flex, Large
BioSphere Flex is a resorbable bone void filler for gaps in the extremities or pelvis that are not needed for structural stability. It fills defects created by surgery or trauma. The…
BioSphere Flex is a resorbable bone void filler for gaps in the extremities or pelvis that are not needed for structural stability. It fills defects created by surgery or trauma. The material must be hydrated with the patient’s own bone marrow aspirate before implantation.
Porous 45S5 bioactive glass granules are held in a collagen and sodium hyaluronate scaffold. The scaffold absorbs fluid and becomes flexible and moldable after hydration. Its porous structure provides surfaces and spaces for new bone formation as the material resorbs.
Preparation and Supply
The material is supplied sterile for a single use. It is gently packed into the prepared bone void after hydration with autogenous bone marrow; this preparation step is required for the intended flexible handling characteristics.
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 | Synergy Biomedical, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K173424 |
| Record published | 2021-06-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BSF-25100 | 15cc | 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 |
|---|---|
| K241167 | 2024-12-20 |
| K173424 | 2018-09-12 |
| K173301 | 2018-01-19 |
| K140844 | 2014-07-16 |
| K122868 | 2013-04-19 |
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.