Nexxt Matrixx® Stand Alone Cervical System
Nexxt Matrixx Stand Alone Cervical System combines a titanium alloy interbody spacer with fixation screws. The spacer is additively manufactured with an external structural frame and…
Nexxt Matrixx Stand Alone Cervical System combines a titanium alloy interbody spacer with fixation screws. The spacer is additively manufactured with an external structural frame and internal geometric lattice. A vertical cavity accommodates bone graft, and locking collets secure the screws to the spacer.
It is intended for anterior fusion at one or two contiguous levels from C2 to T1 in skeletally mature patients with degenerative disc disease. Patients should have had at least six weeks of nonoperative treatment. The supplied bone screws provide fixation without additional fixation hardware.
Listed Item
SA Cervical Assembly, Qty=1 16Dx18Wx12H Interbody and Qty=2 Ø3.5x16mm Screws
Structure and Graft
The spacer has a roughened outer surface and lattice pores of 300 to 700 micrometers. It is implanted through an open anterior approach using autograft or cancellous or corticocancellous allogeneic bone graft. Machined fixation screws and spacers are available in combinations of sizes for patient anatomy.
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K190546 |
| Record published | 2019-08-08 |
| Record revised | 2023-04-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Height 5 to 12 mm; angle 6 °; depth 12 to 16 mm; width 14 to 18 mm; outer diameter 3.5 to 4 mm; length 12 to 18 mm |
| Distribution end date | 2021-09-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I52-30-01 | In distribution | |
| I52-TR68-11 | In distribution | |
| I52-TR46-06 | In distribution | |
| I52-TR68-10 | In distribution | |
| I52-TR46-11 | In distribution | |
| I52-TR24-09 | In distribution | |
| I52-TR24-10 | In distribution | |
| I52-TR46-12 | In distribution | |
| I52-TR24-11 | In distribution | |
| I52-TR46-05 | In distribution | |
| I52-TR68-05 | In distribution | |
| I52-TR24-12 | In distribution | |
| I52-TR68-08 | In distribution | |
| I52-TR68-09 | In distribution | |
| I52-TR46-10 | In distribution | |
| I52-TR68-12 | In distribution | |
| I52-TR46-07 | In distribution | |
| C52-01-02 | In distribution | |
| I52-TR46-09 | In distribution | |
| I52-TR24-05 | In distribution | |
| I52-TR68-06 | In distribution | |
| I52-TR46-08 | In distribution | |
| I52-TR24-07 | In distribution | |
| C52-01-03 | In distribution | |
| I52-TR24-06 | In distribution | |
| I52-TR24-08 | In distribution | |
| I52-TR68-07 | In distribution | |
| C52-01-01 | In distribution | |
| I52-10-1214-09 | Withdrawn | |
| 52-1618-12-ASM | Height 12 mm | Withdrawn |
| C52-02-04 | Withdrawn | |
| I52-10-1416-06 | Withdrawn | |
| 52-40-14-SP | Outer Diameter 4.0 mm | Withdrawn |
| I52-10-1214-06 | Withdrawn | |
| I52-10-1416-07 | Withdrawn | |
| I52-10-01 | Withdrawn | |
| I52-10-1618-09 | Withdrawn | |
| 52-1214-05-ASM | Height 5 mm | Withdrawn |
| I52-30-02 | Withdrawn | |
| 52-1214-06-ASM | Width 14 mm | Withdrawn |
| 52-35-12-SP | Length 12 mm | Withdrawn |
| 52-40-16-SP | Length 16 mm | Withdrawn |
| 52-1618-10-ASM | Height 10 mm | Withdrawn |
| I52-10-1618-07 | Withdrawn | |
| 52-1618-07-SP | Width 18 mm | Withdrawn |
| 52-35-18-SP | Outer Diameter 3.5 mm | Withdrawn |
| 52-1618-06-ASM | Height 6 mm | Withdrawn |
| 52-1618-06-SP | Width 18 mm | Withdrawn |
| 52-1618-08-SP | Width 18 mm | Withdrawn |
| I52-10-1416-08 | Withdrawn | |
| 52-1214-08-SP | Width 14 mm | Withdrawn |
| I52-10-1214-07 | Withdrawn | |
| 52-1214-08-ASM | Width 14 mm | Withdrawn |
| I52-10-1618-05 | Withdrawn | |
| 52-1618-09-SP | Width 18 mm | Withdrawn |
| 52-1416-05-SP | Width 16 mm | Withdrawn |
| 52-1416-12-SP | Width 16 mm | Withdrawn |
| I52-10-1618-12 | Withdrawn | |
| 52-40-12-SP | Length 12 mm | Withdrawn |
| C52-02-01 | Withdrawn | |
| 52-1214-09-ASM | Height 9 mm | Withdrawn |
| I52-10-02 | Withdrawn | |
| I52-10-1416-12 | Withdrawn | |
| C52-02-03 | Withdrawn | |
| I52-10-1214-08 | Withdrawn | |
| I52-10-1214-12 | Withdrawn | |
| I52-10-1618-10 | Withdrawn | |
| 52-35-16-SP | Length 16 mm | Withdrawn |
| I52-10-1618-08 | Withdrawn | |
| 52-1416-06-ASM | Height 6 mm | Withdrawn |
| 52-1416-11-ASM | Width 16 mm | Withdrawn |
| 52-1214-12-SP | Width 14 mm | Withdrawn |
| 52-1416-12-ASM | Height 12 mm | Withdrawn |
| C52-02-02 | Withdrawn | |
| 52-1416-09-SP | Width 16 mm | Withdrawn |
| 52-1618-05-ASM | Width 18 mm | Withdrawn |
| 52-1416-08-SP | Width 16 mm | Withdrawn |
| 52-1416-11-SP | Width 16 mm | Withdrawn |
| I52-10-1618-06 | Withdrawn | |
| 52-1416-10-SP | Width 16 mm | Withdrawn |
| I52-10-1214-11 | Withdrawn | |
| 52-1618-09-ASM | Width 18 mm | Withdrawn |
| 52-1618-12-SP | Width 18 mm | Withdrawn |
| I52-10-1416-09 | Withdrawn | |
| 52-1618-10-SP | Width 18 mm | Withdrawn |
| 52-1214-06-SP | Width 14 mm | Withdrawn |
| 52-1214-09-SP | Width 14 mm | Withdrawn |
| I52-10-1416-10 | Withdrawn | |
| I52-10-1214-05 | Withdrawn | |
| 52-1416-05-ASM | Width 16 mm | Withdrawn |
| 52-1618-05-SP | Width 18 mm | Withdrawn |
| 52-1214-11-ASM | Height 11 mm | Withdrawn |
| 52-1214-10-SP | Width 14 mm | Withdrawn |
| 52-1214-05-SP | Width 14 mm | Withdrawn |
| 52-1618-08-ASM | Height 8 mm | Withdrawn |
| 52-1618-07-ASM | Width 18 mm | Withdrawn |
| 52-35-14-SP | Outer Diameter 3.5 mm | Withdrawn |
| 52-1214-07-ASM | Height 7 mm | Withdrawn |
| 52-1416-10-ASM | Height 10 mm | Withdrawn |
| 52-1416-06-SP | Width 16 mm | Withdrawn |
| I52-10-1214-10 | Withdrawn | |
| 52-1618-11-SP | Width 18 mm | Withdrawn |
| 52-1416-07-SP | Width 16 mm | Withdrawn |
| 52-1416-09-ASM | Width 16 mm | Withdrawn |
| 52-1214-12-ASM | Height 12 mm | Withdrawn |
| 52-1618-11-ASM | Width 18 mm | Withdrawn |
| 52-1214-10-ASM | Width 14 mm | Withdrawn |
| 52-1214-11-SP | Width 14 mm | Withdrawn |
| 52-1416-07-ASM | Width 16 mm | Withdrawn |
| 52-1214-07-SP | Width 14 mm | Withdrawn |
| I52-01-01 | Withdrawn | |
| I52-10-1416-05 | Withdrawn | |
| C52-02-05 | Withdrawn | |
| I52-10-1618-11 | Withdrawn | |
| I52-10-1416-11 | Withdrawn | |
| 52-1416-08-ASM | Height 8 mm | Withdrawn |
| 52-40-18-SP | Outer Diameter 4.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200543 | 2020-03-23 |
| K190546 | 2019-05-31 |
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.