LumFix Spinal Fixation System
LumFix Spinal Fixation System is a posterior spinal construct assembled from pedicle screws, set screws, rods and crosslinks. Its top-loading components provide immobilization and…
LumFix Spinal Fixation System is a posterior spinal construct assembled from pedicle screws, set screws, rods and crosslinks. Its top-loading components provide immobilization and stabilization as an adjunct to fusion in the thoracic, lumbar and sacral spine.
The implants come in various sizes and are made from titanium alloy, with a cobalt-chromium-molybdenum rod option. Components are supplied nonsterile and are intended for single use.
Listed Item
Regulation Name : Pedicle screw spinal system
Fusion and Removal
Use is for skeletally mature patients receiving autogenous bone graft, with implant removal after solid fusion. Indications include Grade 3 or 4 L5-S1 spondylolisthesis, degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion.
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | CG BIO Co., Ltd., South Korea |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K160731 |
| Record published | 2019-10-17 |
| Record revised | 2025-07-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RDPS5050 | In distribution | |
| RDPS5540 | In distribution | |
| RODST55500 | In distribution | |
| RDPS6540 | In distribution | |
| RDPS5530 | In distribution | |
| RDPS5545 | In distribution | |
| RDPS7540 | In distribution | |
| RODST55400 | In distribution | |
| RDPS5550 | In distribution | |
| RODCR5540 | In distribution | |
| NPSS4530 | In distribution | |
| RDPS5030 | In distribution | |
| RDPS5535 | In distribution | |
| RDPS6055 | In distribution | |
| RDPS6035 | In distribution | |
| CROSSB15076 | In distribution | |
| RDPS5045 | In distribution | |
| RDPS6555 | In distribution | |
| RDPS6535 | In distribution | |
| RDPS7550 | In distribution | |
| RODCR55100 | In distribution | |
| RDPS7545 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160731 | 2016-10-04 |
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.