BioSphere Flex SP
BioSphere Flex is a resorbable bone void filler for gaps in the extremities and pelvis that do not provide structural stability. It is gently packed into surgically created defects or…
BioSphere Flex is a resorbable bone void filler for gaps in the extremities and pelvis that do not provide structural stability. It is gently packed into surgically created defects or defects caused by traumatic bone injury. The material must be hydrated with the patient’s own bone marrow before implantation.
Porous bioactive glass granules sit within a scaffold of collagen and sodium hyaluronate. Hydration makes the scaffold flexible and moldable so it can fit the defect. Its porous structure provides surfaces and space for bone formation as the material resorbs and is replaced by host bone.
Supply and Scope
The filler is supplied sterile for single use. It is intended to fill nonstructural bone gaps; the defect must not be intrinsic to the stability of the surrounding bony structure.
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 | 2020-01-31 |
| Record revised | 2020-06-19 (version 2) |
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 |
| Sizes | Total volume 7.5 to 15 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Medium | Total Volume 7.5 ml | In distribution |
| Large | Total Volume 15 ml | 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.