Signafuse Bioactive Bone Graft
Signafuse Bioactive Bone Graft fills skeletal voids or gaps that do not provide intrinsic structural stability. It combines biphasic mineral granules and 45S5 bioactive glass in a porous…
Signafuse Bioactive Bone Graft fills skeletal voids or gaps that do not provide intrinsic structural stability. It combines biphasic mineral granules and 45S5 bioactive glass in a porous Type I collagen matrix.
The sterile material is mixed with the patient’s bone marrow aspirate before packing into defects of the extremities, pelvis or posterolateral spine. It provides an osteoconductive scaffold that resorbs as host bone replaces it.
Listed Item
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Spinal Use and Supply
In the posterolateral spine, Signafuse is used as an autograft extender. Defects may be surgically created or caused by trauma. The collagen comes from bovine material, and the finished graft is sterilized by gamma irradiation.
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 | Bioventus LLC, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K193513 |
| Record published | 2020-07-30 |
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 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50X25X8 MM, 10 CC | In distribution | |
| 100X25X8 MM, 20 CC | In distribution | |
| 200X25X8 MM, 40 CC | In distribution | |
| 25X25X8 MM, 5 CC | 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 |
|---|---|
| K233490 | 2023-12-05 |
| K193513 | 2020-06-18 |
| K162860 | 2017-02-13 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-02-13 | Class II | Package design/selection | The firm became aware of the potential for the products’ sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection. | 10,793 | 2020-11-02 |
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.