M.u.s.t. Polyaxial Pedicle Screw
M.u.s.t. Polyaxial Pedicle Screw is a spinal fixation component used with rods to create a stabilization construct. Screws fix into the pedicles and vertebrae, with cannulated and…
M.u.s.t. Polyaxial Pedicle Screw is a spinal fixation component used with rods to create a stabilization construct. Screws fix into the pedicles and vertebrae, with cannulated and noncannulated options within the system.
Screw diameters range from 4.5 to 7 mm and lengths from 20 to 90 mm. Color anodizing identifies shaft diameter, and a dual-lead thread reduces the turns needed for insertion. Compatible connecting rods are 5.5 mm.
Listed Item
Cannul. Pedicle screw 6x60mm + Nut (1x) – Sterile
Construct and Indications
The construct is secured with cobalt-chromium-molybdenum set screws and uses titanium alloy or cobalt-chromium-molybdenum rods. It is an adjunct to fusion in skeletally mature patients for specified degenerative disease, trauma, deformity, tumor, pseudarthrosis or failed fusion. Sterile and nonsterile packaging options are described.
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medacta International SA, Switzerland |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K121115 |
| Record published | 2014-09-17 |
| Record revised | 2024-10-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03.50.015 | In distribution | |
| 03.50.001 | In distribution | |
| 03.52.021 | In distribution | |
| 03.52.028 | In distribution | |
| 03.50.028 | In distribution | |
| 03.50.009 | In distribution | |
| 03.50.011 | In distribution | |
| 03.52.032 | In distribution | |
| 03.50.013 | In distribution | |
| 03.52.034 | In distribution | |
| 03.52.040 | In distribution | |
| 03.50.019 | In distribution | |
| 03.52.030 | In distribution | |
| 03.50.017 | In distribution | |
| 03.50.054 | In distribution | |
| 03.50.032 | In distribution | |
| 03.50.021 | In distribution | |
| 03.52.036 | In distribution | |
| 03.52.008 | In distribution | |
| 03.50.034 | In distribution | |
| 03.50.036 | In distribution | |
| 03.50.040 | In distribution | |
| 03.50.030 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121115 | 2012-07-18 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medacta Usa Inc | 510(k) number | 2016-12-07 | Class II | Packaging | Damaged packaging, lack of sterility assurance | 82 units | 2017-11-15 |
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.