Kainos+
KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). KAINOS+ is available in various…
KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). KAINOS+ is available in various shapes and sizes. KAINOS+ may be used with physiolo-gical saline, patient’s own serum, whole blood, or bone marrow aspirate (BMA).
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 | Signus Medizintechnik Gmbh, Germany |
|---|---|
| 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, Exporter |
| 510(k) | K090387 |
| Record published | 2015-09-24 |
| Record revised | 2020-06-19 (version 8) |
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 |
| Storage | Storage environment temperature 0 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Bone graft substitute, granulate 2-3mm | 1x6cm³ | In distribution |
| Bone graft substitute, insert for NUBIC | 4x13x14mm | In distribution |
| Bone graft substitute, granules 1-2mm | 1x5cm³ | In distribution |
| Bone graft substitute, granules 2-3mm | 1x5cm³ | In distribution |
| Bone graft substitute, granules 2-3mm | 1x20cm³ | In distribution |
| Bone graft substitute, insert for NUBIC | 5x13x14mm | In distribution |
| Bone graft substitute, insert for NUBIC | 7x13x14mm | In distribution |
| Bone graft substitute, granules 1-2mm | 2x5cm³ | In distribution |
| Bone graft substitute, granules 2-3mm | 1x3cm³ | In distribution |
| Bone graft substitute, granules 2-3mm | 1x30cm³ | In distribution |
| Bone graft substitute, granules 2-3mm | 1x10cm³ | In distribution |
| Bone graft substitute, insert for NUBIC | 8x13x14mm | In distribution |
| Bone graft substitute, insert for NUBIC | 6x13x14mm | 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 |
|---|---|
| K090387 | 2009-09-28 |
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.