ProMIS™ Fixation System
ProMIS Fixation System is a lumbar spinal fixation family with fusion rods, polyaxial pedicle screws and set screws. The screws anchor the construct to bone, and rods connect the fixation…
ProMIS Fixation System is a lumbar spinal fixation family with fusion rods, polyaxial pedicle screws and set screws. The screws anchor the construct to bone, and rods connect the fixation points during fusion.
The titanium alloy implant range includes straight or bent rods and solid or cannulated screws. Screw bodies have self-tapping flutes, with rounded or self-drilling tip configurations.
Listed Item
Pre Bent Rod Ø6.0x190mm Blunt Edge The ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
Supply by Rod Length
Pedicle screws and rods up to 100 mm are supplied sterile after gamma irradiation. Rods longer than 100 mm are supplied nonsterile for steam sterilization by the user. This length-dependent supply distinction applies to the rod component within the system.
15manufacturers in China registered for this device type
112catalogue numbers in this listing
5510(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 | Premia Spine Ltd., Israel |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K231844 |
| Record published | 2024-01-17 |
| Record revised | 2024-09-02 (version 5) |
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 |
| Storage | Storage environment temperature 15 to 22 °C; Storage environment humidity 0 to 70 % RH |
| Sizes | Length 35 to 500 mm; outer diameter 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 87681 | Length 270 mm | In distribution |
| 87512 | Length 270 mm | In distribution |
| 87658 | Length 90 mm | In distribution |
| 87659 | Length 95 mm | In distribution |
| 87666 | Length 130 mm | In distribution |
| 86241 | Length 40 mm | In distribution |
| 87482 | Length 70 mm | In distribution |
| 87651 | Length 55 mm | In distribution |
| 87508 | Length 190 mm | In distribution |
| 87652 | Length 60 mm | In distribution |
| 86255 | Outer Diameter 6 mm | In distribution |
| 86418 | Length 175 mm | In distribution |
| 87510 | Length 220 mm | In distribution |
| 87656 | Length 80 mm | In distribution |
| 86410 | Length 125 mm | In distribution |
| 87493 | Length 110 mm | In distribution |
| 87675 | Length 175 mm | In distribution |
| 87655 | Length 75 mm | In distribution |
| 86404 | Length 75 mm | In distribution |
| 87499 | Length 140 mm | In distribution |
| 87498 | Length 135 mm | In distribution |
| 87682 | Length 340 mm | In distribution |
| 87479 | Length 55 mm | In distribution |
| 87653 | Length 65 mm | In distribution |
| 87650 | Length 35 mm | In distribution |
| 87515 | Length 210 mm | In distribution |
| 87347 | Length 500 mm | In distribution |
| 87501 | Length 150 mm | In distribution |
| 87648 | Length 40 mm | In distribution |
| 86403 | Length 65 mm | In distribution |
| 86243 | Length 60 mm | In distribution |
| 86401 | Length 45 mm | In distribution |
| 86874 | Outer Diameter 6 mm | In distribution |
| 87678 | Length 200 mm | In distribution |
| 86242 | Length 50 mm | In distribution |
| 87649 | Length 45 mm | In distribution |
| 87663 | Length 115 mm | In distribution |
| 87664 | Length 120 mm | In distribution |
| 87673 | Length 165 mm | In distribution |
| 87481 | Length 65 mm | In distribution |
| 86872 | Length 200 mm | In distribution |
| 87497 | Length 130 mm | In distribution |
| 87349 | Length 300 mm | In distribution |
| 87676 | Length 180 mm | In distribution |
| 87316 | Length 340 mm | In distribution |
| 86407 | Length 105 mm | In distribution |
| 87483 | Length 75 mm | In distribution |
| 86257 | Length 160 mm | In distribution |
| 87668 | Length 140 mm | In distribution |
| 87505 | Length 170 mm | In distribution |
| 87506 | Length 175 mm | In distribution |
| 86256 | Length 140 mm | In distribution |
| 87345 | Length 350 mm | In distribution |
| 87346 | Length 400 mm | In distribution |
| 86244 | Length 70 mm | In distribution |
| 87475 | Length 35 mm | In distribution |
| 86245 | Length 80 mm | In distribution |
| 86415 | Length 155 mm | In distribution |
| 87671 | Length 155 mm | In distribution |
| 87661 | Length 105 mm | In distribution |
| 86411 | Length 130 mm | In distribution |
| 87667 | Length 135 mm | In distribution |
| 87662 | Length 110 mm | In distribution |
| 87503 | Length 160 mm | In distribution |
| 87509 | Length 200 mm | In distribution |
| 87489 | Length 90 mm | In distribution |
| 87674 | Length 170 mm | In distribution |
| 87669 | Length 145 mm | In distribution |
| 87490 | Length 95 mm | In distribution |
| 87491 | Length 100 mm | In distribution |
| 87495 | Length 120 mm | In distribution |
| 86406 | Length 95 mm | In distribution |
| 87476 | Length 40 mm | In distribution |
| 87502 | Length 155 mm | In distribution |
| 86409 | Length 115 mm | In distribution |
| 86416 | Length 165 mm | In distribution |
| 86413 | Length 145 mm | In distribution |
| 87670 | Length 150 mm | In distribution |
| 87654 | Length 70 mm | In distribution |
| 87683 | Length 250 mm | In distribution |
| 87496 | Length 125 mm | In distribution |
| 87511 | Length 250 mm | In distribution |
| 86247 | Length 100 mm | In distribution |
| 87513 | Length 300 mm | In distribution |
| 86408 | Outer Diameter 6 mm | In distribution |
| 87679 | Length 210 mm | In distribution |
| 86402 | Length 55 mm | In distribution |
| 87478 | Length 50 mm | In distribution |
| 87477 | Length 45 mm | In distribution |
| 86414 | Length 150 mm | In distribution |
| 87660 | Length 100 mm | In distribution |
| 87514 | Length 340 mm | In distribution |
| 87492 | Length 105 mm | In distribution |
| 86871 | Length 190 mm | In distribution |
| 87487 | Length 80 mm | In distribution |
| 87488 | Length 85 mm | In distribution |
| 87647 | Length 35 mm | In distribution |
| 87657 | Length 85 mm | In distribution |
| 86873 | Length 210 mm | In distribution |
| 86794 | Length 35 mm | In distribution |
| 87500 | Length 35 mm | In distribution |
| 87665 | Length 125 mm | In distribution |
| 87504 | Length 165 mm | In distribution |
| 86405 | Length 85 mm | In distribution |
| 87680 | Length 220 mm | In distribution |
| 87507 | Length 180 mm | In distribution |
| 87677 | Length 190 mm | In distribution |
| 87494 | Length 115 mm | In distribution |
| 87480 | Length 60 mm | In distribution |
| 86246 | Length 90 mm | In distribution |
| 87684 | Length 270 mm | In distribution |
| 87672 | Length 160 mm | In distribution |
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 |
|---|---|
| K232719 | 2023-11-21 |
| K231844 | 2023-07-07 |
| K182598 | 2018-11-13 |
| K170061 | 2017-02-02 |
| K150380 | 2015-07-17 |
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.