SCS 17-01
SCS 17-01 is an injectable bone graft substitute for filling voids in the extremities and pelvis that do not determine the stability of the bone. It forms a paste that sets after placement…
SCS 17-01 is an injectable bone graft substitute for filling voids in the extremities and pelvis that do not determine the stability of the bone. It forms a paste that sets after placement and converts to hydroxyapatite at body temperature. Its calcium phosphate structure serves as a scaffold during bone replacement.
The clinician mixes a dry powder and an aqueous solution during surgery using the supplied mixing system. The components form a cohesive paste for implantation. The material is resorbable and is intended to be replaced by new bone during healing.
Listed Item
SCS 17-01 is a synthetic, injectable, settable osteoconductive calcium phosphate bone graft substitute material.
Components
The powder contains tricalcium phosphate, calcium carbonate and monocalcium phosphate. The solution contains sodium phosphate, citric acid, hyaluronic acid and water. The sterile single use kit provides the components in preloaded syringes.
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 | Anika Therapeutics, Inc., 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, Manufacturer, Exporter |
| 510(k) | K173008 |
| Record published | 2019-07-22 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6000041 | 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 |
|---|---|
| K231968 | 2023-12-20 |
| K223915 | 2023-03-29 |
| K212083 | 2021-08-31 |
| K190956 | 2020-01-30 |
| K173008 | 2017-12-26 |
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.