Matrixx System
The NEXXT MATRIXX System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The filing describes the implants as structural…
The NEXXT MATRIXX System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The filing describes the implants as structural columns for surgical stabilization of the spine.
Its corpectomy devices are indicated to replace diseased, collapsed, damaged or unstable vertebral bodies in specified cervical and thoracolumbar levels. Open devices include a vertical cavity for bone graft, while solid devices are closed and intended for partial vertebral-body replacement.
Listed Item
Corpectomy, 16Dx18Wx52H 6°
Implant Construction
The filing describes an external structural frame with roughened surface and geometric lattices. The implants are Ti-6Al-4V ELI alloy, with open and solid options across listed dimensions and lordotic angles.
1manufacturer
88catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shandong. 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 |
Record
| Listed by | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | PLR |
| Device type | Spinal Vertebral Body Replacement Device – Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K193412 |
| Record published | 2025-03-19 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Depth 16 mm; width 18 mm; height 10 to 70 mm; angle 0 to 6 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 53-1618-52-6-SP | Depth 16 mm | In distribution |
| 53-1618-63-0-SP | Depth 16 mm | In distribution |
| 53-1618-30-0-SP | Depth 16 mm | In distribution |
| 53-1618-17-0-SP | Depth 16 mm | In distribution |
| 53-1618-59-0-SP | Depth 16 mm | In distribution |
| 53-1618-41-6-SP | Depth 16 mm | In distribution |
| 53-1618-52-0-SP | Depth 16 mm | In distribution |
| 53-1618-43-6-SP | Depth 16 mm | In distribution |
| 53-1618-62-6-SP | Depth 16 mm | In distribution |
| 53-1618-56-6-SP | Depth 16 mm | In distribution |
| 53-1618-10-6-SP | Depth 16 mm | In distribution |
| 53-1618-68-0-SP | Depth 16 mm | In distribution |
| 53-1618-56-0-SP | Depth 16 mm | In distribution |
| 53-1618-35-0-SP | Depth 16 mm | In distribution |
| 53-1618-58-6-SP | Depth 16 mm | In distribution |
| 53-1618-39-6-SP | Depth 16 mm | In distribution |
| 53-1618-53-0-SP | Depth 16 mm | In distribution |
| 53-1618-24-0-SP | Depth 16 mm | In distribution |
| 53-1618-34-0-SP | Depth 16 mm | In distribution |
| 53-1618-26-0-SP | Depth 16 mm | In distribution |
| 53-1618-31-6-SP | Depth 16 mm | In distribution |
| 53-1618-57-6-SP | Depth 16 mm | In distribution |
| 53-1618-14-0-SP | Depth 16 mm | In distribution |
| 53-1618-50-0-SP | Depth 16 mm | In distribution |
| 53-1618-61-0-SP | Depth 16 mm | In distribution |
| 53-1618-22-0-SP | Depth 16 mm | In distribution |
| 53-1618-45-0-SP | Depth 16 mm | In distribution |
| 53-1618-35-6-SP | Depth 16 mm | In distribution |
| 53-1618-60-6-SP | Depth 16 mm | In distribution |
| 53-1618-65-0-SP | Depth 16 mm | In distribution |
| 53-1618-25-0-SP | Depth 16 mm | In distribution |
| 53-1618-57-0-SP | Depth 16 mm | In distribution |
| 53-1618-62-0-SP | Depth 16 mm | In distribution |
| 53-1618-53-6-SP | Depth 16 mm | In distribution |
| 53-1618-18-0-SP | Depth 16 mm | In distribution |
| 53-1618-21-0-SP | Depth 16 mm | In distribution |
| 53-1618-70-6-SP | Depth 16 mm | In distribution |
| 53-1618-48-0-SP | Depth 16 mm | In distribution |
| 53-1618-51-0-SP | Depth 16 mm | In distribution |
| 53-1618-68-6-SP | Depth 16 mm | In distribution |
| 53-1618-37-6-SP | Depth 16 mm | In distribution |
| 53-1618-64-6-SP | Depth 16 mm | In distribution |
| 53-1618-41-0-SP | Depth 16 mm | In distribution |
| 53-1618-54-0-SP | Depth 16 mm | In distribution |
| 53-1618-36-0-SP | Depth 16 mm | In distribution |
| 53-1618-37-0-SP | Depth 16 mm | In distribution |
| 53-1618-49-0-SP | Depth 16 mm | In distribution |
| 53-1618-54-6-SP | Depth 16 mm | In distribution |
| 53-1618-55-6-SP | Depth 16 mm | In distribution |
| 53-1618-49-6-SP | Depth 16 mm | In distribution |
| 53-1618-16-0-SP | Depth 16 mm | In distribution |
| 53-1618-63-6-SP | Depth 16 mm | In distribution |
| 53-1618-47-0-SP | Depth 16 mm | In distribution |
| 53-1618-60-0-SP | Depth 16 mm | In distribution |
| 53-1618-45-6-SP | Depth 16 mm | In distribution |
| 53-1618-55-0-SP | Depth 16 mm | In distribution |
| 53-1618-66-6-SP | Depth 16 mm | In distribution |
| 53-1618-23-0-SP | Depth 16 mm | In distribution |
| 53-1618-38-0-SP | Depth 16 mm | In distribution |
| 53-1618-47-6-SP | Depth 16 mm | In distribution |
| 53-1618-64-0-SP | Depth 16 mm | In distribution |
| 53-1618-42-0-SP | Depth 16 mm | In distribution |
| 53-1618-67-0-SP | Depth 16 mm | In distribution |
| 53-1618-39-0-SP | Depth 16 mm | In distribution |
| 53-1618-69-0-SP | Depth 16 mm | In distribution |
| 53-1618-59-6-SP | Depth 16 mm | In distribution |
| 53-1618-15-0-SP | Depth 16 mm | In distribution |
| 53-1618-28-0-SP | Depth 16 mm | In distribution |
| 53-1618-46-0-SP | Depth 16 mm | In distribution |
| 53-1618-13-0-SP | Depth 16 mm | In distribution |
| 53-1618-65-6-SP | Depth 16 mm | In distribution |
| 53-1618-58-0-SP | Depth 16 mm | In distribution |
| 53-1618-27-0-SP | Depth 16 mm | In distribution |
| 53-1618-40-0-SP | Depth 16 mm | In distribution |
| 53-1618-32-0-SP | Depth 16 mm | In distribution |
| 53-1618-44-0-SP | Depth 16 mm | In distribution |
| 53-1618-70-0-SP | Depth 16 mm | In distribution |
| 53-1618-43-0-SP | Depth 16 mm | In distribution |
| 53-1618-61-6-SP | Depth 16 mm | In distribution |
| 53-1618-19-0-SP | Depth 16 mm | In distribution |
| 53-1618-66-0-SP | Depth 16 mm | In distribution |
| 53-1618-69-6-SP | Depth 16 mm | In distribution |
| 53-1618-29-0-SP | Depth 16 mm | In distribution |
| 53-1618-67-6-SP | Depth 16 mm | In distribution |
| 53-1618-51-6-SP | Depth 16 mm | In distribution |
| 53-1618-31-0-SP | Depth 16 mm | In distribution |
| 53-1618-33-6-SP | Depth 16 mm | In distribution |
| 53-1618-33-0-SP | Depth 16 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alta | Astura Medical | 290 |
| Ascend | Alphatec Spine, Inc. | 267 |
| Colosseum | Globus Medical, Inc. | 87 |
| Palo Alto Corpectomy Cage System | VB Spine LLC | 56 |
| C-VBR | VB Spine LLC | 53 |
| Trabis® | Coligne AG | 34 |
| X-Core | Nuvasive, Inc. | 31 |
| CarboClear Cervical VBR System | CarboFix Orthopedics, Ltd. | 31 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 25 |
| Zavation | Zavation | 25 |
| Verteloc Spinal System | Signature Orthopaedics PTY Limited | 17 |
| Fortify | Globus Medical, Inc. | 14 |
Showing 12 of 31. All products under Spinal Vertebral Body Replacement Device – Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193412 | 2020-02-24 |
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.