Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)
The Blustone Synergy Silica implant replaces a vertebral body removed partly or completely because of a tumor, trauma or fracture. It is intended for the thoracolumbar spine from T1 to L5,…
The Blustone Synergy Silica implant replaces a vertebral body removed partly or completely because of a tumor, trauma or fracture. It is intended for the thoracolumbar spine from T1 to L5, where it provides structural support after removal of the affected bone. It must be used with supplemental spinal fixation and autograft or allograft bone.
The implant is made from PEEK and incorporates tantalum markers to help the surgeon position it under imaging. Parallel and lordotic configurations in different heights accommodate the patient’s anatomy. It is placed through an anterior surgical approach.
Listed Item
The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configurations of various heights. The implants are designed with a 15mm x 13mm footprint in heights ranging from 20 to 50mm in three (3) mm increments. The device is hollow to allow for placement of autograft and/or allogenic bone graft and facilitate fusion, and contains tantalum markers to assist the surgeon with proper placement of the device. The device may be implanted as a single device via an anterior approach.
Implantation
The implant is placed using device specific and general surgical instruments.
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Blustone Synergy, LLC, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K172330 |
| Record published | 2018-01-29 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Width 13 mm; length 15 mm; height 20 to 50 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1513-C050 | Width 13 mm | In distribution |
| 1513-C320 | Width 13 mm | In distribution |
| 1513-C044 | Width 13 mm | In distribution |
| 1513-C338 | Width 13 mm | In distribution |
| 1513-C035 | Width 13 mm | In distribution |
| 1513-C023 | Width 13 mm | In distribution |
| 1513-C020 | Width 13 mm | In distribution |
| 1513-C332 | Width 13 mm | In distribution |
| 1513-C335 | Width 13 mm | In distribution |
| 1513-C341 | Width 13 mm | In distribution |
| 1513-C026 | Width 13 mm | In distribution |
| 1513-C326 | Height 26 mm | In distribution |
| 1513-C323 | Height 23 mm | In distribution |
| 1513-C029 | Width 13 mm | In distribution |
| 1513-C347 | Width 13 mm | In distribution |
| 1513-C350 | Width 13 mm | In distribution |
| 1513-C344 | Width 13 mm | In distribution |
| 1513-C032 | Width 13 mm | In distribution |
| 1513-C041 | Width 13 mm | In distribution |
| 1513-C038 | Width 13 mm | In distribution |
| 1513-C329 | Width 13 mm | In distribution |
| 1513-C047 | Width 13 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172330 | 2017-12-21 |
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.