Erisma®-MIS
The Erisma LP MIS uniplanar screw is a component of a posterior percutaneous spinal fixation system. It is used with rods to immobilize and stabilize thoracic, lumbar or sacral spinal…
The Erisma LP MIS uniplanar screw is a component of a posterior percutaneous spinal fixation system. It is used with rods to immobilize and stabilize thoracic, lumbar or sacral spinal segments in skeletally mature patients as an adjunct to fusion.
The MIS family uses extended pedicle screws and straight or prebent rods in different lengths and diameters. Implant components are titanium alloy, with uniplanar screws added as a configuration within the system.
Listed Item
Lateral MIS Uniplanar Screw
Fixation Indications
Indications include degenerative disc disease, specified spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, tumor and failed fusion. The MIS components are intended for noncervical posterior pedicle fixation; the screws provide one part of the complete fixation construct.
15manufacturers in China registered for this device type
87catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
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 | Clariance, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K241863 |
| Record published | 2024-09-02 |
| Record revised | 2024-09-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 4.5 to 10.5 mm; length 20 to 100 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13059540 | Outer Diameter 9.5 mm | In distribution |
| 13054530 | Outer Diameter 4.5 mm | In distribution |
| 13058595 | Outer Diameter 8.5 mm | In distribution |
| 13057535 | Outer Diameter 7.5 mm | In distribution |
| 13055540 | Outer Diameter 5.5 mm | In distribution |
| 13051080 | Outer Diameter 10.5 mm | In distribution |
| 13058560 | Outer Diameter 8.5 mm | In distribution |
| 13054535 | Outer Diameter 4.5 mm | In distribution |
| 13051040 | Outer Diameter 10.5 mm | In distribution |
| 13059535 | Outer Diameter 9.5 mm | In distribution |
| 13054525 | Outer Diameter 4.5 mm | In distribution |
| 13051045 | Outer Diameter 10.5 mm | In distribution |
| 13056545 | Outer Diameter 6.5 mm | In distribution |
| 13058525 | Outer Diameter 8.5 mm | In distribution |
| 13057540 | Outer Diameter 7.5 mm | In distribution |
| 13056525 | Outer Diameter 6.5 mm | In distribution |
| 13056560 | Outer Diameter 6.5 mm | In distribution |
| 13058565 | Outer Diameter 8.5 mm | In distribution |
| 13058550 | Outer Diameter 8.5 mm | In distribution |
| 13055525 | Outer Diameter 5.5 mm | In distribution |
| 13057575 | Outer Diameter 7.5 mm | In distribution |
| 13056540 | Outer Diameter 6.5 mm | In distribution |
| 13051035 | Outer Diameter 10.5 mm | In distribution |
| 13051025 | Outer Diameter 10.5 mm | In distribution |
| 13051090 | Outer Diameter 10.5 mm | In distribution |
| 13059570 | Outer Diameter 9.5 mm | In distribution |
| 13057595 | Outer Diameter 7.5 mm | In distribution |
| 13057530 | Outer Diameter 7.5 mm | In distribution |
| 13051085 | Outer Diameter 10.5 mm | In distribution |
| 13059580 | Outer Diameter 9.5 mm | In distribution |
| 13054520 | Outer Diameter 4.5 mm | In distribution |
| 13055520 | Outer Diameter 5.5 mm | In distribution |
| 13058540 | Outer Diameter 8.5 mm | In distribution |
| 13059555 | Outer Diameter 9.5 mm | In distribution |
| 13055545 | Outer Diameter 5.5 mm | In distribution |
| 13058530 | Outer Diameter 8.5 mm | In distribution |
| 13057555 | Outer Diameter 7.5 mm | In distribution |
| 13058545 | Outer Diameter 8.5 mm | In distribution |
| 13055530 | Outer Diameter 5.5 mm | In distribution |
| 13058510 | Outer Diameter 8.5 mm | In distribution |
| 13056550 | Outer Diameter 6.5 mm | In distribution |
| 13057550 | Outer Diameter 7.5 mm | In distribution |
| 13051070 | Outer Diameter 10.5 mm | In distribution |
| 13058590 | Outer Diameter 8.5 mm | In distribution |
| 13057565 | Outer Diameter 7.5 mm | In distribution |
| 13057570 | Outer Diameter 7.5 mm | In distribution |
| 13059510 | Outer Diameter 9.5 mm | In distribution |
| 13055535 | Outer Diameter 5.5 mm | In distribution |
| 13051065 | Outer Diameter 10.5 mm | In distribution |
| 13051075 | Outer Diameter 10.5 mm | In distribution |
| 13058570 | Outer Diameter 8.5 mm | In distribution |
| 13055550 | Outer Diameter 5.5 mm | In distribution |
| 13058580 | Outer Diameter 8.5 mm | In distribution |
| 13059525 | Outer Diameter 9.5 mm | In distribution |
| 13057585 | Outer Diameter 7.5 mm | In distribution |
| 13057545 | Outer Diameter 7.5 mm | In distribution |
| 13055555 | Outer Diameter 5.5 mm | In distribution |
| 13057580 | Outer Diameter 7.5 mm | In distribution |
| 13059590 | Outer Diameter 9.5 mm | In distribution |
| 13056535 | Outer Diameter 6.5 mm | In distribution |
| 13058575 | Outer Diameter 8.5 mm | In distribution |
| 13059550 | Outer Diameter 9.5 mm | In distribution |
| 13051055 | Outer Diameter 10.5 mm | In distribution |
| 13059575 | Outer Diameter 9.5 mm | In distribution |
| 13057590 | Outer Diameter 7.5 mm | In distribution |
| 13051060 | Outer Diameter 10.5 mm | In distribution |
| 13051030 | Outer Diameter 10.5 mm | In distribution |
| 13059560 | Outer Diameter 9.5 mm | In distribution |
| 13057510 | Outer Diameter 7.5 mm | In distribution |
| 13057525 | Outer Diameter 7.5 mm | In distribution |
| 13056530 | Outer Diameter 6.5 mm | In distribution |
| 13058555 | Outer Diameter 8.5 mm | In distribution |
| 13059545 | Outer Diameter 9.5 mm | In distribution |
| 13059595 | Outer Diameter 9.5 mm | In distribution |
| 13059530 | Outer Diameter 9.5 mm | In distribution |
| 13051010 | Outer Diameter 10.5 mm | In distribution |
| 13051095 | Outer Diameter 10.5 mm | In distribution |
| 13054540 | Outer Diameter 4.5 mm | In distribution |
| 13051050 | Outer Diameter 10.5 mm | In distribution |
| 13056555 | Outer Diameter 6.5 mm | In distribution |
| 13059565 | Outer Diameter 9.5 mm | In distribution |
| 13059585 | Outer Diameter 9.5 mm | In distribution |
| 13056520 | Outer Diameter 6.5 mm | In distribution |
| 13058585 | Outer Diameter 8.5 mm | In distribution |
| 13054545 | Outer Diameter 4.5 mm | In distribution |
| 13058535 | Outer Diameter 8.5 mm | In distribution |
| 13057560 | Outer Diameter 7.5 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 |
|---|---|
| K241863 | 2024-07-24 |
| K240872 | 2024-04-26 |
| K170163 | 2017-02-14 |
| K162367 | 2016-10-27 |
| K153326 | 2016-03-08 |
| K120469 | 2012-08-13 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-07-01 | Class III | Use error | Potential for the polyaxial screw to become disassembled during implant. | 4,090 units distributed in the US | 2020-07-09 |
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.