Threshold V2 Pedicle Screw
The Threshold V2 Pedicle Screw anchors a posterior spinal fixation construct used as an adjunct to fusion. The system provides immobilization and stabilization in skeletally mature patients…
The Threshold V2 Pedicle Screw anchors a posterior spinal fixation construct used as an adjunct to fusion. The system provides immobilization and stabilization in skeletally mature patients with thoracic, lumbar or sacral instability or deformity. It is intended for noncervical fixation.
The screw is made from titanium alloy and works with compatible rods and connectors to build the fixation construct. Screws can follow a conventional transpedicular trajectory or other specified pedicle trajectories to accommodate surgical and anatomical requirements.
Conditions of Use
System indications include degenerative disc disease, spondylolisthesis, fracture or dislocation, spinal stenosis, deformity, tumor, pseudarthrosis and failed previous fusion. Coated and uncoated screw options are available.
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 | Spineology Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K172107 |
| Record published | 2017-09-21 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 25 to 50 mm |
| Distribution end date | 2024-07-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-10-78-41 | 45×4.5 | In distribution |
| 10-10-78-38 | Length 30 mm | In distribution |
| 10-10-78-42 | Length 50 mm | In distribution |
| 10-10-78-37 | 25×4.5 | In distribution |
| 10-10-78-39 | 35×4.5 | In distribution |
| 10-10-78-40 | Length 40 mm | In distribution |
| 10-10-80-84 | Length 40 mm | Withdrawn |
| 10-10-80-82 | 30×4.5 | Withdrawn |
| 10-10-80-81 | 25×4.5 | Withdrawn |
| 10-10-80-85 | 45×4.5 | Withdrawn |
| 10-10-80-83 | 35×4.5 | Withdrawn |
| 10-10-80-86 | 50×4.5 | Withdrawn |
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 |
|---|---|
| K172107 | 2017-08-21 |
| K171438 | 2017-06-02 |
| K170268 | 2017-04-14 |
| K170251 | 2017-04-14 |
| K170266 | 2017-04-14 |
| K170255 | 2017-04-14 |
| K161694 | 2016-07-15 |
| K160980 | 2016-05-26 |
| K153323 | 2016-02-23 |
| K152148 | 2015-09-02 |
| K143403 | 2014-12-18 |
| K140010 | 2014-04-23 |
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.