Solidity Vertebral Body Replacement
Solidity is an expandable vertebral-body replacement for mechanical support after thoracic or lumbar corpectomy. A cylindrical centre piece provides expansion, and end caps establish the…
Solidity is an expandable vertebral-body replacement for mechanical support after thoracic or lumbar corpectomy. A cylindrical centre piece provides expansion, and end caps establish the contact footprint against the remaining anatomy.
The components are Ti-6Al-4V ELI titanium alloy. Different expansion ranges, endplate angles and footprints allow the assembled replacement to match the reconstruction.
Listed Item
Center piece, turquoise, Ø 13mm, height 19-27.5mm, one fixed end cap, one variable end cap
Replacement and Fixation
Solidity is intended for open procedures from T1 to L5 to replace a collapsed, damaged or unstable vertebral body affected by tumor or trauma. Supplemental spinal fixation is required. Bone graft is optional for this vertebral-body replacement configuration.
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 | Ulrich Medical USA, Inc., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K181921 |
| Record published | 2018-12-27 |
| Record revised | 2021-06-25 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UU041-03-1300 | In distribution | |
| UU042-02-02 | In distribution | |
| UU041-01-1621 | In distribution | |
| UU041-02-1300 | In distribution | |
| UU041-01-3551 | In distribution | |
| UU041-01-2839 | In distribution | |
| UU043-02-01 | In distribution | |
| UU041-02-1605 | In distribution | |
| UU042-01-03 | In distribution | |
| UU042-01-02 | In distribution | |
| UU041-01-1317 | In distribution | |
| UU043-03-01 | In distribution | |
| UU041-03-1600 | In distribution | |
| UU042-03-02 | In distribution | |
| UU043-01-02 | In distribution | |
| UU042-02-01 | In distribution | |
| UU041-01-4772 | In distribution | |
| UU041-01-1927 | In distribution | |
| UU041-03-1305 | In distribution | |
| UU042-01-04 | In distribution | |
| UU043-01-01 | In distribution | |
| UU041-03-1610 | In distribution | |
| UU042-03-04 | In distribution | |
| UU043-03-02 | In distribution | |
| UU042-02-04 | In distribution | |
| UU041-03-1605 | In distribution | |
| UU042-03-01 | In distribution | |
| UU041-04-1600 | In distribution | |
| UU042-04-02 | In distribution | |
| UU042-02-03 | In distribution | |
| UU041-03-1310 | In distribution | |
| UU041-02-1310 | In distribution | |
| UU041-01-2432 | In distribution | |
| UU042-04-01 | In distribution | |
| UU041-02-1305 | In distribution | |
| UU041-02-1600 | In distribution | |
| UU042-03-05 | In distribution | |
| UU041-02-1610 | In distribution | |
| UU042-01-01 | 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 |
|---|---|
| K181921 | 2018-11-16 |
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.