Threshold Solid Pedicle Screw
The filing concerns uncoated and hydroxyapatite-coated solid pedicle screws added to the Threshold Pedicular Fixation System. It describes the system as intended for posterior, non-cervical…
The filing concerns uncoated and hydroxyapatite-coated solid pedicle screws added to the Threshold Pedicular Fixation System. It describes the system as intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients.
The filing says the solid screws may be placed in pedicles in a variety of trajectories. It lists system uses that include degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvature, tumor, pseudoarthrosis and failed prior fusion.
Scope of the Filing
The submission states that the added solid screws retain the system’s intended use and indications. The filing describes them as available uncoated or with a hydroxyapatite coating.
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) | K161694 |
| Record published | 2016-08-03 |
| Record revised | 2024-11-07 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 30 to 100 mm |
| Distribution end date | 2024-07-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-10-78-2 | Length 35 mm | In distribution |
| 10-10-79-3 | Length 90 mm | In distribution |
| 10-10-78-13 | 30×6.5 | In distribution |
| 10-10-78-28 | Length 65 mm | In distribution |
| 10-10-78-5 | Length 50 mm | In distribution |
| 10-10-78-20 | 65×6.5 | In distribution |
| 10-10-79-2 | Length 80 mm | In distribution |
| 10-10-78-14 | 35×6.5 | In distribution |
| 10-10-78-11 | Length 55 mm | In distribution |
| 10-10-78-31 | 40×8.5 | In distribution |
| 10-10-80-27 | Length 60 mm | Withdrawn |
| 10-10-80-25 | 50×7.5 | Withdrawn |
| 10-10-80-9 | 45×5.5 | Withdrawn |
| 10-10-80-23 | Length 40 mm | Withdrawn |
| 10-10-80-11 | 55×5.5 | Withdrawn |
| 10-10-80-7 | Length 35 mm | Withdrawn |
| 10-10-80-40 | Length 100 mm | Withdrawn |
| 10-10-80-16 | 45×6.5 | Withdrawn |
| 10-10-80-6 | 30×5.5 | Withdrawn |
| 10-10-80-38 | 80×8.5 | Withdrawn |
| 10-10-80-19 | Length 60 mm | Withdrawn |
| 10-10-80-26 | Length 55 mm | 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.