Inertia® Connexx™ Modular Pedicle Screw System
INERTIA CONNEXX is a modular pedicle screw system for stabilizing the posterior, non-cervical spine during fusion. Rods, pedicle screws and fasteners form the implanted construct, with…
INERTIA CONNEXX is a modular pedicle screw system for stabilizing the posterior, non-cervical spine during fusion. Rods, pedicle screws and fasteners form the implanted construct, with different component sizes to accommodate anatomical requirements.
The implants are made from Ti-6Al-4V ELI titanium alloy and are supplied in sterile or nonsterile configurations. Driver shafts and other placement tools belong to the associated instrumentation rather than the implanted rod-and-screw assembly.
Listed Item
Modular Shank Driver, Inner Shaft, Cannulated
Fixation Scope
The system provides fixation from T1 through S2 and the ilium in skeletally mature patients. Its pediatric use is limited to posterior pedicle screw fixation for adolescent idiopathic scoliosis, with autograft or allograft used as part of the fusion procedure.
15manufacturers in China registered for this device type
1,241catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K221905 |
| Record published | 2022-11-08 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 4.5 to 200 mm; length 20 to 600 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-UDS-75100 | Outer Diameter 7.5 mm | In distribution |
| 20-SDC-7550 | Outer Diameter 7.5 mm | In distribution |
| 20-SCS-5020 | Outer Diameter 5.0 mm | In distribution |
| 20-28R-40 | Outer Diameter 40 mm | In distribution |
| 20-SCS-85105 | Outer Diameter 8.5 mm | In distribution |
| 20-SCR-8595 | Outer Diameter 8.5 mm | In distribution |
| 20-RS55-180J | Outer Diameter 5.5 mm | In distribution |
| 20-HS-01-SP | In distribution | |
| C20-02-28 | In distribution | |
| 20-SCR-9560 | Outer Diameter 9.5 mm | In distribution |
| I20-08-12 | In distribution | |
| 20-SCR-C-5540 | Outer Diameter 5.5 mm | In distribution |
| 20-SDC-7535 | Outer Diameter 7.5 mm | In distribution |
| 20-RC55-140 | Outer Diameter 5.5 mm | In distribution |
| C20-02-11 | In distribution | |
| 20-SDC-7070 | Outer Diameter 7.0 mm | In distribution |
| 20-UDS-4560 | Outer Diameter 4.5 mm | In distribution |
| 20-SCR-5550 | Outer Diameter 5.5 mm | In distribution |
| 20-SCC-5075 | Outer Diameter 5.0 mm | In distribution |
| 20-SDC-5040 | Outer Diameter 5.0 mm | In distribution |
| 20-SCC-5030 | Outer Diameter 5.0 mm | In distribution |
| 20-SDS-4540 | Outer Diameter 4.5 mm | In distribution |
| 20-SCC-6595 | Outer Diameter 6.5 mm | In distribution |
| 20-SDS-6060 | Outer Diameter 6.0 mm | In distribution |
| 20-UDS-7570 | Outer Diameter 7.5 mm | In distribution |
| 20-27L-65 | Length 65 mm | In distribution |
| 20-SCR-10560 | Outer Diameter 10.5 mm | In distribution |
| 20-SDC-85105 | Outer Diameter 8.5 mm | In distribution |
| 20-UDR-5540 | Outer Diameter 5.5 mm | In distribution |
| 20-SCR-8580 | Outer Diameter 8.5 mm | In distribution |
| 20-SCC-7050 | Outer Diameter 7.0 mm | In distribution |
| 20-SCC-7535 | Outer Diameter 7.5 mm | In distribution |
| 20-UDS-4570 | Outer Diameter 4.5 mm | In distribution |
| 20-SCS-9580 | Outer Diameter 9.5 mm | In distribution |
| 20-SCC-5580 | Outer Diameter 5.5 mm | In distribution |
| 20-RC55-140J | Outer Diameter 5.5 mm | In distribution |
| 20-SDC-6550 | Outer Diameter 6.5 mm | In distribution |
| 20-SCR-6555 | Outer Diameter 6.5 mm | In distribution |
| 10-6-60125 | Outer Diameter 6.0 mm | In distribution |
| I20-08-06L | T25 | In distribution |
| 20-SCS-6565 | Outer Diameter 6.5 mm | In distribution |
| 20-SCS-9565 | Outer Diameter 9.5 mm | In distribution |
| 20-25-25 | Length 25 mm | In distribution |
| 20-MIS-MS-4540 | Outer Diameter 4.5 mm | In distribution |
| 10-6-60120 | Outer Diameter 6.0 mm | In distribution |
| 20-SCR-5555 | Outer Diameter 5.5 mm | In distribution |
| I20-16-06 | In distribution | |
| 10-6-6065-SP | Outer Diameter 6.0 mm | In distribution |
| 20-HD-01 | In distribution | |
| I20-08-13 | In distribution | |
| 20-SCR-115120 | Outer Diameter 11.5 mm | In distribution |
| 20-SDS-6560 | Outer Diameter 6.5 mm | In distribution |
| 20-SDS-105120 | Outer Diameter 10.5 mm | In distribution |
| 20-SCR-11575 | Outer Diameter 11.5 mm | In distribution |
| 20-SCR-7560 | Outer Diameter 7.5 mm | In distribution |
| 10-6-6040-SP | Outer Diameter 6.0 mm | In distribution |
| 10-7-6055 | Outer Diameter 6.0 mm | In distribution |
| 20-SDC-6050 | Length 50 mm | In distribution |
| 20-SCR-85105 | Outer Diameter 8.5 mm | In distribution |
| 20-UDR-5555 | Length 55 mm | In distribution |
| 10-7-5585-SP | Outer Diameter 5.5 mm | In distribution |
| 20-SCS-5520-SP | Outer Diameter 5.5 mm | In distribution |
| 10-6-5565-SP | Outer Diameter 5.5 mm | In distribution |
| 20-SCS-5535-SP | Outer Diameter 5.5 mm | In distribution |
| I20-18-03 | In distribution | |
| 20-SDC-7560 | Outer Diameter 7.5 mm | In distribution |
| 20-UDS-5530 | Outer Diameter 5.5 mm | In distribution |
| 20-SDC-7575 | Outer Diameter 7.5 mm | In distribution |
| 20-SDC-4535 | Outer Diameter 4.5 mm | In distribution |
| 20-MIS-M-8555 | Outer Diameter 8.5 mm | In distribution |
| 10-7-6040-SP | Outer Diameter 6.0 mm | In distribution |
| 20-UDS-4525 | Outer Diameter 4.5 mm | In distribution |
| 20-SDS-6535-SP | Outer Diameter 6.5 mm | In distribution |
| 20-UDS-6540 | Outer Diameter 6.5 mm | In distribution |
| 20-SDS-105100 | Outer Diameter 10.5 mm | In distribution |
| 20-SCC-7530 | Outer Diameter 7.5 mm | In distribution |
| 20-RC55-090-SP | Outer Diameter 5.5 mm | In distribution |
| 20-SDC-9555 | Outer Diameter 9.5 mm | In distribution |
| 20-SCS-6060 | Outer Diameter 6.0 mm | In distribution |
| 20-SCS-7595 | Outer Diameter 7.5 mm | In distribution |
| 20-SDS-6080 | Outer Diameter 6.0 mm | In distribution |
| 20-RC55-040J | Outer Diameter 5.5 mm | In distribution |
| 20-SCS-85110 | Outer Diameter 8.5 mm | In distribution |
| 20-SDS-6540-SP | Outer Diameter 6.5 mm | In distribution |
| 20-SCC-6540 | Outer Diameter 6.5 mm | In distribution |
| 20-SCS-7585 | Outer Diameter 7.5 mm | In distribution |
| 20-SDS-10555 | Outer Diameter 10.5 mm | In distribution |
| 20-28L-40 | Outer Diameter 40 mm | In distribution |
| 10-7-6060-SP | Outer Diameter 6.0 mm | In distribution |
| 20-RC55-055-SP | Outer Diameter 5.5 mm | In distribution |
| 20-UDS-4535 | Outer Diameter 4.5 mm | In distribution |
| 20-SDS-7045 | Outer Diameter 7.0 mm | In distribution |
| 20-SDC-7525 | Outer Diameter 7.5 mm | In distribution |
| 20-SDS-7075 | Outer Diameter 7.0 mm | In distribution |
| 20-RC55-045-SP | Outer Diameter 5.5 mm | In distribution |
| 20-SCC-6025 | Outer Diameter 6.0 mm | In distribution |
| 20-SDS-6585 | Outer Diameter 6.5 mm | In distribution |
| 20-RC55-075J | Outer Diameter 5.5 mm | In distribution |
| I20-16-01L | T25 | In distribution |
| 20-SDS-4545 | Outer Diameter 4.5 mm | In distribution |
| 20-UDS-6535 | Outer Diameter 6.5 mm | In distribution |
| 20-UDR-7585 | Length 85 mm | In distribution |
| 20-RS55-250J | Outer Diameter 5.5 mm | In distribution |
| I20-08-06 | In distribution | |
| 20-SCC-7580 | Outer Diameter 7.5 mm | In distribution |
| 20-SCC-7575 | Outer Diameter 7.5 mm | In distribution |
| 20-SDC-4525 | Outer Diameter 4.5 mm | In distribution |
| 20-SDC-8580 | Outer Diameter 8.5 mm | In distribution |
| 10-7-5540-SP | Outer Diameter 5.5 mm | In distribution |
| 20-SCS-7545 | Outer Diameter 7.5 mm | In distribution |
| 20-RC55-055 | Outer Diameter 5.5 mm | In distribution |
| 20-SCC-7540 | Outer Diameter 7.5 mm | In distribution |
| 20-UDS-5540 | Outer Diameter 5.5 mm | In distribution |
| 20-SCC-6585 | Outer Diameter 6.5 mm | In distribution |
| 20-MIS-S-5550 | Outer Diameter 5.5 mm | In distribution |
| 20-UDR-7520 | Length 20 mm | In distribution |
| 20-27R-65 | Length 65 mm | In distribution |
| 20-RC55-040 | Outer Diameter 5.5 mm | In distribution |
| 20-SCC-6590 | Outer Diameter 6.5 mm | In distribution |
| 20-27R-150 | Length 150 mm | In distribution |
| 20-SCS-8580 | Outer Diameter 8.5 mm | In distribution |
| 10-6-6055 | Outer Diameter 6.0 mm | In distribution |
| 20-MIS-M-5025 | Outer Diameter 5.0 mm | In distribution |
| 20-SCS-7025 | Outer Diameter 7.0 mm | In distribution |
| 20-SDC-7530 | Outer Diameter 7.5 mm | In distribution |
| 20-UDS-6580 | Outer Diameter 6.5 mm | In distribution |
| 20-28R-80 | Outer Diameter 80 mm | In distribution |
| 20-RC55-085 | Outer Diameter 5.5 mm | In distribution |
| 20-RC55-145J | Outer Diameter 5.5 mm | In distribution |
| 20-SDC-85110 | Outer Diameter 8.5 mm | In distribution |
| 20-SDS-5580 | Outer Diameter 5.5 mm | In distribution |
| 10-6-6070-SP | Outer Diameter 6.0 mm | In distribution |
| 20-UDR-6555 | Length 55 mm | In distribution |
| 20-SCC-6555 | Outer Diameter 6.5 mm | In distribution |
| 20-SCR-9540 | Outer Diameter 9.5 mm | In distribution |
| 10-6-6045-SP | Outer Diameter 6.0 mm | In distribution |
| 20-SDC-4530 | Outer Diameter 4.5 mm | In distribution |
| 20-SCS-5565 | Outer Diameter 5.5 mm | In distribution |
| 20-UDR-6590 | Length 90 mm | In distribution |
| 20-SCC-6530 | Outer Diameter 6.5 mm | In distribution |
| 20-28R-20 | Outer Diameter 20 mm | In distribution |
| 20-SDS-7030 | Outer Diameter 7.0 mm | In distribution |
| 20-UDR-6585 | Length 85 mm | In distribution |
| 20-SDS-95110 | Outer Diameter 9.5 mm | In distribution |
| 20-SCS-65100 | Outer Diameter 6.5 mm | In distribution |
| 20-UDS-6595 | Outer Diameter 6.5 mm | In distribution |
| 10-7-60400 | Outer Diameter 6.0 mm | In distribution |
| I20-10-16 | In distribution | |
| 20-SDS-6595 | Outer Diameter 6.5 mm | In distribution |
| 20-RZ-100200 | In distribution | |
| 20-25-30 | Length 30 mm | In distribution |
| 20-SDC-5580 | Outer Diameter 5.5 mm | In distribution |
| 20-SDC-4560 | Outer Diameter 4.5 mm | In distribution |
| 20-SDC-6075 | Outer Diameter 6.0 mm | In distribution |
| 20-SDS-85105 | Outer Diameter 8.5 mm | In distribution |
| 10-6-5540-SP | Outer Diameter 5.5 mm | In distribution |
| 20-SCC-8595 | Outer Diameter 8.5 mm | In distribution |
| 20-SDC-8560 | Outer Diameter 8.5 mm | In distribution |
| 20-MIS-M-5545 | Outer Diameter 5.5 mm | In distribution |
| 10-7-60120 | Outer Diameter 6.0 mm | In distribution |
| 10-6-60150 | Outer Diameter 6.0 mm | In distribution |
| 20-SCC-8575 | Outer Diameter 8.5 mm | In distribution |
| 20-SDC-8575 | Outer Diameter 8.5 mm | In distribution |
| 20-SDC-5555 | Outer Diameter 5.5 mm | In distribution |
| 20-SDC-6585 | Outer Diameter 6.5 mm | In distribution |
| 10-7-5570-SP | Outer Diameter 5.5 mm | In distribution |
| C20-01-09 | In distribution | |
| 20-SDC-8540-SP | Outer Diameter 8.5 mm | In distribution |
| 20-SCR-10580 | Outer Diameter 10.5 mm | In distribution |
| 20-SDC-6540 | Outer Diameter 6.5 mm | In distribution |
| 20-28R-50 | Outer Diameter 50 mm | In distribution |
| C20-01-14 | In distribution | |
| 20-RC55-130 | Outer Diameter 5.5 mm | In distribution |
| 20-SDS-5540-SP | Outer Diameter 5.5 mm | In distribution |
| I20-08-05L | T25 | In distribution |
| 20-SCS-6560 | Outer Diameter 6.5 mm | In distribution |
| 20-SDS-11590 | Outer Diameter 11.5 mm | In distribution |
| 20-SCR-115105 | Outer Diameter 11.5 mm | In distribution |
| 20-SCS-7590 | Outer Diameter 7.5 mm | In distribution |
| 20-SCR-10595 | Outer Diameter 10.5 mm | In distribution |
| 20-MIS-S-6555 | Tower Height Short | In distribution |
| 20-SDC-8545 | Outer Diameter 8.5 mm | In distribution |
| 20-SCR-9575 | Outer Diameter 9.5 mm | In distribution |
| 20-SDC-8590 | Outer Diameter 8.5 mm | In distribution |
| 20-SDS-11560 | Outer Diameter 11.5 mm | In distribution |
| 20-SCS-7575 | Outer Diameter 7.5 mm | In distribution |
| 20-SCR-8530 | Outer Diameter 8.5 mm | In distribution |
| 20-SDS-6530-SP | Outer Diameter 6.5 mm | In distribution |
| 20-SDC-5065 | Outer Diameter 5.0 mm | In distribution |
| 20-SDC-7555 | Outer Diameter 7.5 mm | In distribution |
| 20-SCS-7535 | Outer Diameter 7.5 mm | In distribution |
| 20-MIS-L-7555 | Outer Diameter 7.5 mm | In distribution |
| 20-SCS-8540-SP | Outer Diameter 8.5 mm | In distribution |
| 20-SDS-5560 | Outer Diameter 5.5 mm | In distribution |
| 20-SCS-6055 | Outer Diameter 6.0 mm | In distribution |
| 20-RS55-250 | Outer Diameter 5.5 mm | In distribution |
| 20-SDS-6565 | Outer Diameter 6.5 mm | In distribution |
| 20-UDR-6520 | Length 20 mm | In distribution |
| 20-SDC-6575 | Outer Diameter 6.5 mm | In distribution |
| 10-7-60350 | Outer Diameter 6.0 mm | In distribution |
| 20-UDS-5535 | Outer Diameter 5.5 mm | In distribution |
| 20-SDS-115110 | Outer Diameter 11.5 mm | In distribution |
| C20-02-65LS | In distribution | |
| 20-SCS-6050 | Outer Diameter 6.0 mm | In distribution |
| 20-SCR-C-6560 | Outer Diameter 6.5 mm | In distribution |
| 10-7-5550-SP | Outer Diameter 5.5 mm | In distribution |
| 20-RS55-180 | Outer Diameter 5.5 mm | In distribution |
| 20-RC55-035 | Outer Diameter 5.5 mm | In distribution |
| 20-UDR-7525 | Length 25 mm | In distribution |
| 20-SCS-5025 | Outer Diameter 5.0 mm | In distribution |
| 20-MIS-M-5555 | Outer Diameter 5.5 mm | In distribution |
| 10-7-6070 | Outer Diameter 6.0 mm | In distribution |
| 20-SDC-75100 | Outer Diameter 7.5 mm | In distribution |
| I20-08-02 | In distribution | |
| 20-MIS-S-6550 | Outer Diameter 6.5 mm | In distribution |
| 20-SDC-5525 | Outer Diameter 5.5 mm | In distribution |
| 20-SCC-9555 | Outer Diameter 9.5 mm | In distribution |
| 20-MIS-M-5035 | Outer Diameter 5.0 mm | In distribution |
| 20-MIS-MS-4525 | Outer Diameter 4.5 mm | In distribution |
| 20-SDS-85100 | Outer Diameter 8.5 mm | In distribution |
| 20-SCS-6075 | Outer Diameter 6.0 mm | In distribution |
| 20-SDC-5060 | Outer Diameter 5.0 mm | In distribution |
| 20-RC55-115J | Outer Diameter 5.5 mm | In distribution |
| 20-SDS-5020-SP | Outer Diameter 5.0 mm | In distribution |
| 20-SCR-105100 | Outer Diameter 10.5 mm | In distribution |
| 20-SCR-7565 | Outer Diameter 7.5 mm | In distribution |
| 20-SDS-5530 | Outer Diameter 5.5 mm | In distribution |
| 20-SCR-C-5535 | Outer Diameter 5.5 mm | In distribution |
| 20-SCC-7565 | Outer Diameter 7.5 mm | In distribution |
| 20-SDS-10585 | Outer Diameter 10.5 mm | In distribution |
| 20-UDR-6535 | Outer Diameter 6.5 mm | In distribution |
| 20-UDR-5545 | Outer Diameter 5.5 mm | In distribution |
| 20-28R-90 | Outer Diameter 90 mm | In distribution |
| 20-SDS-5550-SP | Outer Diameter 5.5 mm | In distribution |
| 20-SCC-5045 | Outer Diameter 5.0 mm | In distribution |
| 20-ETL-01-SP | In distribution | |
| 20-SDC-5030 | Outer Diameter 5.0 mm | In distribution |
| 20-SDC-6035 | Outer Diameter 6.0 mm | In distribution |
| 20-SDS-5070 | Outer Diameter 5.0 mm | In distribution |
| 20-SDS-115115 | Outer Diameter 11.5 mm | In distribution |
| 20-SDC-4565 | Outer Diameter 4.5 mm | In distribution |
| 20-UDR-6570 | Length 70 mm | In distribution |
| 20-28L-100 | Outer Diameter 100 mm | In distribution |
| 20-UDR-6550 | Length 50 mm | In distribution |
| 20-SCR-6540 | Outer Diameter 6.5 mm | In distribution |
| 20-UDS-5580 | Outer Diameter 5.5 mm | In distribution |
| 20-RC55-080J | Outer Diameter 5.5 mm | In distribution |
| C20-01-08 | In distribution | |
| 20-SDC-6570 | Outer Diameter 6.5 mm | In distribution |
| 20-SCS-5520 | Outer Diameter 5.5 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231799 | 2023-07-20 |
| K221905 | 2022-07-28 |
| K153453 | 2016-04-26 |
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.