Bicera® Resorbable Bone Substitute
Bicera Resorbable Bone Substitute is a ceramic bone void filler composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate. It is intended to fill surgically created bone defects or…
Bicera Resorbable Bone Substitute is a ceramic bone void filler composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate. It is intended to fill surgically created bone defects or defects caused by traumatic injury. The material gradually resorbs and is replaced by bone during healing.
The filler is packed into voids or gaps in the extremities, posterolateral spine or pelvis. These gaps must not be intrinsic to the stability of the bony structure. Bicera therefore serves as a defect filler within the specified skeletal sites.
Listed Item
Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Material and Supply
The ceramic has an interconnected porous structure and is supplied sterile in different shapes and sizes. Its calcium salt composition and porosity form the physical structure of the graft substitute. Selection of the supplied shape and size corresponds to the bone defect being filled.
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 | Wiltrom Corporation Limited, Taiwan |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K172237 |
| Record published | 2020-12-29 |
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 23 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BC-G27(2.0-3.0mm,15c.c.) | In distribution | |
| BC-B01(5x5x20mm,2c.c.) | In distribution | |
| BC-G01(2.0-3.0mm,5c.c.) | In distribution | |
| BC-G10(0.25-0.5mm,0.25g) | In distribution | |
| BC-B06(5x5x20mm,5c.c.) | In distribution | |
| BC-G07(1.0-2.0mm,10c.c.) | In distribution | |
| BC-G06(1.0-2.0mm,7c.c.) | In distribution | |
| BC-B11 (5x5x10mm,20c.c.) | In distribution | |
| BC-G26(1.0-2.0mm,30c.c.) | In distribution | |
| BC-G12(0.25-0.5mm,1g) | In distribution | |
| BC-G02(1.0-2.0mm,5c.c.) | In distribution | |
| BC-G03(0.5-1.0mm,5c.c.) | In distribution | |
| BC-B07(5x5x20mm,7c.c.) | In distribution | |
| BC-G13(0.5-1.0mm,0.25g) | In distribution | |
| BC-G25(1.0-2.0mm,20c.c.) | In distribution | |
| BC-G28(2.0-3.0mm,20c.c.) | In distribution | |
| BC-G16(1.0-2.0mm,0.25g) | In distribution | |
| BC-B05(5x5x10mm,10c.c.) | In distribution | |
| BC-G14(0.5-1.0mm,0.5g) | In distribution | |
| BC-G29(2.0-3.0mm,30c.c.) | In distribution | |
| BC-G04(2.0-3.0mm,7c.c.) | In distribution | |
| BC-G19 (1.0-2.0mm,1.5g) | In distribution | |
| BC-B02(5x5x10mm,2c.c.) | In distribution | |
| BC-G05(2.0-3.0mm,10c.c.) | In distribution | |
| BC-G24(1.0-2.0mm,15c.c.) | In distribution | |
| BC-B03(5x5x10mm,5c.c.) | In distribution | |
| BC-B09 (5x5x20mm,20c.c.) | In distribution | |
| BC-G23(0.5-1.0mm,2c.c.) | In distribution | |
| BC-G17(1.0-2.0mm,0.5g) | In distribution | |
| BC-G22(1.0-2.0mm,2c.c.) | In distribution | |
| BC-G18(1.0-2.0mm,1.0g) | In distribution | |
| BC-G08(0.5-1.0mm,7c.c.) | In distribution | |
| BC-G21(2.0-3.0mm,2c.c.) | In distribution | |
| BC-G20(2.0-3.0mm,0.25g) | In distribution | |
| BC-G09(0.5-1.0mm,10c.c.) | In distribution | |
| BC-B10 (5x5x20mm,30c.c.) | In distribution | |
| BC-B08 (5x5x20mm,10c.c.) | In distribution | |
| BC-G11(0.25-0.5mm,0.5g) | In distribution | |
| BC-B12 (5x5x10mm,30c.c.) | In distribution | |
| BC-B04(5x5x10mm,7c.c.) | In distribution | |
| BC-G15(0.5-1.0mm,1g) | 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 |
| 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 |
| Cem-Ostetic Putty | Berkeley Advanced Biomaterials | 34 |
Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180758 | 2018-10-24 |
| K172237 | 2018-02-02 |
| K110949 | 2012-09-18 |
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.