Biosorb
Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
2manufacturers in China registered for this device type
65catalogue numbers in this listing
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 | S.B.M |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| 510(k) | K021963 |
| Record published | 2015-09-24 |
| Record revised | 2022-09-26 (version 6) |
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, manufacturing date |
| Sizes | Height 3 to 15 mm; total volume 0.13 to 45 ml; length 4 to 25 mm; width 3 to 10 mm; outer diameter 1 to 8 mm |
| Distribution end date | 2020-01-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BIO1 Stick | Total Volume 0.9 ml | In distribution |
| BIO1 Granules | Total Volume 10 ml | In distribution |
| BIO1 Granules | Total Volume 5 ml | In distribution |
| BIO1 Macroporous | Length 4 mm | In distribution |
| BIO1 Stick | Total Volume 2.5 ml | In distribution |
| BIO1 Stick | Length 10 mm | In distribution |
| BIO1 Granules | Total Volume 45 ml | In distribution |
| OTIS | Height 9 mm | In distribution |
| BIO1 Granules | Outer Diameter 1 mm | In distribution |
| BIO1 Cylinder | Outer Diameter 8 mm | Withdrawn |
| OTIS | Height 7 mm | Withdrawn |
| BIO1 Granules | Outer Diameter 3 mm | Withdrawn |
| BIO1 Cubes | Total Volume 0.35 ml | Withdrawn |
| OTIS | Height 15 mm | Withdrawn |
| BIO1 Cubes | Width 5 mm | Withdrawn |
| BIO1 Block | Width 10 mm | Withdrawn |
| BIO1 Cubes | Total Volume 0.26 ml | Withdrawn |
| OTIS 50 | Height 14 mm | Withdrawn |
| BIO1 Cubes | Width 7 mm | Withdrawn |
| OTIS 50 | Height 6 mm | Withdrawn |
| OTIS | Height 12 mm | Withdrawn |
| BIO1 Cubes | Width 10 mm | Withdrawn |
| BIO1 Cubes | Width 5 mm | Withdrawn |
| BIO1 Cubes | Width 10 mm | Withdrawn |
| OTIS | Height 6 mm | Withdrawn |
| OTIS 50 | Height 10 mm | Withdrawn |
| OTIS 50 | Height 12 mm | Withdrawn |
| BIO1 Granules | Total Volume 0.6 ml | Withdrawn |
| OTIS 50 | Height 9 mm | Withdrawn |
| BIO1 Granules | Total Volume 15 ml | Withdrawn |
| BIO1 Granules | Total Volume 15 ml | Withdrawn |
| BIO1 Cubes | Total Volume 2 ml | Withdrawn |
| BIO1 Granules | Total Volume 5 ml | Withdrawn |
| BIO1 Granules | Outer Diameter 1 mm | Withdrawn |
| OTIS | Height 11 mm | Withdrawn |
| BIO1 Cubes | Total Volume 10 ml | Withdrawn |
| OTIS 50 | Height 15 mm | Withdrawn |
| BIO1 Cubes | Width 10 mm | Withdrawn |
| BIO1 Cubes | Total Volume 1.3 ml | Withdrawn |
| BIO1 Stick | Length 20 mm | Withdrawn |
| BIO1 Cubes | Total Volume 5.25 ml | Withdrawn |
| OTIS | Height 10 mm | Withdrawn |
| BIO1 Stick | Length 10 mm | Withdrawn |
| OTIS | Height 13 mm | Withdrawn |
| BIO1 Cylinder | Outer Diameter 6 mm | Withdrawn |
| BIO1 Cubes | Total Volume 0.65 ml | Withdrawn |
| BIO1 Granules | Outer Diameter 1.5 mm | Withdrawn |
| OTIS 50 | Height 7 mm | Withdrawn |
| OTIS 50 | Height 11 mm | Withdrawn |
| BIO1 Stick | Total Volume 10 ml | Withdrawn |
| OTIS | Height 14 mm | Withdrawn |
| BIO1 Cylinder | Total Volume 2.8 ml | Withdrawn |
| BIO1 Macroporous | Total Volume 15 ml | Withdrawn |
| BIO1 Granules | Total Volume 5 ml | Withdrawn |
| BIO1 Granules | Outer Diameter 3 mm | Withdrawn |
| BIO1 Granules | Outer Diameter 1.5 mm | Withdrawn |
| BIO1 Cubes | Width 5 mm | Withdrawn |
| OTIS | Height 8 mm | Withdrawn |
| BIO1 Block | Total Volume 2.5 ml | Withdrawn |
| OTIS 50 | Height 13 mm | Withdrawn |
| OTIS 50 | Height 8 mm | Withdrawn |
| BIO1 Stick | Total Volume 5 ml | Withdrawn |
| BIO1 Cubes | Total Volume 1.75 ml | Withdrawn |
| BIO1 Cubes | Width 7 mm | Withdrawn |
| BIO1 Stick | Length 20 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synthacer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 360 |
| Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 357 |
| 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 |
| Cem-Ostetic Putty | Berkeley Advanced Biomaterials | 34 |
Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound
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 |
|---|---|---|---|---|---|---|
| Science & BIO Materials, S.B.M. SAS | 510(k) number | 2025-04-07 | Class II | Process control | Vials of implant bone granules may contain less product then specified on labeling. | 30 vials |
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.