Erisma®-LP
Erisma LP is a pedicle-screw fixation family that stabilizes vertebrae during fusion. The implant range combines cannulated or noncannulated monoaxial and polyaxial screws with rods,…
Erisma LP is a pedicle-screw fixation family that stabilizes vertebrae during fusion. The implant range combines cannulated or noncannulated monoaxial and polyaxial screws with rods, crosslinks and offset connectors.
The implants are Ti-6Al-4V titanium alloy. The updated range also includes uniplanar screws, alongside the established screw and rod configurations.
Listed Item
Beveled pedicle targeting needle
Approach and Instrument Groups
The LP system supports noncervical posterior fixation, while the related LP MIS configuration uses extended cannulated screws and straight or prebent rods for percutaneous access. Associated instruments support the system; a listed pedicle-targeting needle belongs to the instrument group rather than the implanted screw-and-rod assembly.
15manufacturers in China registered for this device type
1,010catalogue 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 | 2024-08-09 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 1.5 to 10.5 mm; length 20 to 540 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15044545 | Outer Diameter 4.5 mm | In distribution |
| 18475508 | Outer Diameter 5.5 mm | In distribution |
| 18019560 | Length 60 mm | In distribution |
| 18151030 | Length 30 mm | In distribution |
| 13620009 | In distribution | |
| 13014545 | Length 45 mm | In distribution |
| 15047510 | Outer Diameter 7.5 mm | In distribution |
| 15051030 | Outer Diameter 10.5 mm | In distribution |
| 18455510 | Length 100 mm | In distribution |
| 18161065 | Outer Diameter 10.5 mm | In distribution |
| 18455520 | Length 200 mm | In distribution |
| 18475526 | Outer Diameter 5.5 mm | In distribution |
| 18475544 | Length 440 mm | In distribution |
| 18455512 | Length 120 mm | In distribution |
| 15041085 | Outer Diameter 10.5 mm | In distribution |
| 15057595 | Outer Diameter 7.5 mm | In distribution |
| 13707003 | In distribution | |
| 15059525 | Outer Diameter 9.5 mm | In distribution |
| 18525045 | Outer Diameter 5.5 mm | In distribution |
| 18188550 | Length 50 mm | In distribution |
| 15058535 | Outer Diameter 8.5 mm | In distribution |
| 15061045 | Outer Diameter 10.5 mm | In distribution |
| 13720001 | In distribution | |
| 18455506 | Length 60 mm | In distribution |
| 13037580 | Length 80 mm | In distribution |
| 18037545 | Length 45 mm | In distribution |
| 18744003 | In distribution | |
| 18181030 | Length 30 mm | In distribution |
| 18177530 | Length 30 mm | In distribution |
| 18017595 | Length 95 mm | In distribution |
| 15059575 | Outer Diameter 9.5 mm | In distribution |
| 15058570 | Outer Diameter 8.5 mm | In distribution |
| 13025520 | Outer Diameter 5.5 mm | In distribution |
| 18161085 | Outer Diameter 10.5 mm | In distribution |
| 18455522 | Length 220 mm | In distribution |
| 15048590 | Outer Diameter 8.5 mm | In distribution |
| 15064530 | Outer Diameter 4.5 mm | In distribution |
| 15049570 | Outer Diameter 9.5 mm | In distribution |
| 13026530 | Length 30 mm | In distribution |
| 18525035 | Outer Diameter 5.5 mm | In distribution |
| 15067560 | Outer Diameter 7.5 mm | In distribution |
| 18189595 | Outer Diameter 9.5 mm | In distribution |
| 13495340 | Length 340 mm | In distribution |
| 15041075 | Outer Diameter 10.5 mm | In distribution |
| 18164520 | Outer Diameter 4.5 mm | In distribution |
| 18164535 | Length 35 mm | In distribution |
| 18535320 | Outer Diameter 5.5 mm | In distribution |
| 18045530 | Length 30 mm | In distribution |
| 18116545 | Length 45 mm | In distribution |
| 18535340 | Length 340 mm | In distribution |
| 15049595 | Outer Diameter 9.5 mm | In distribution |
| 99701875 | Outer Diameter 7.5 mm | In distribution |
| 18118535 | Outer Diameter 8.5 mm | In distribution |
| 13037560 | Length 60 mm | In distribution |
| 18011070 | Length 70 mm | In distribution |
| 15059570 | Outer Diameter 9.5 mm | In distribution |
| 13021040 | Length 40 mm | In distribution |
| 15041050 | Outer Diameter 10.5 mm | In distribution |
| 15056530 | Outer Diameter 6.5 mm | In distribution |
| 13019530 | Length 30 mm | In distribution |
| 18119595 | Outer Diameter 9.5 mm | In distribution |
| 18188535 | Outer Diameter 8.5 mm | In distribution |
| 15064540 | Outer Diameter 4.5 mm | In distribution |
| 15051070 | Outer Diameter 10.5 mm | In distribution |
| 18535200 | Length 200 mm | In distribution |
| 18038585 | Length 85 mm | In distribution |
| 13026520 | Length 20 mm | In distribution |
| 18017580 | Length 80 mm | In distribution |
| 13026560 | Length 60 mm | In distribution |
| 18525070 | Outer Diameter 5.5 mm | In distribution |
| 18443037 | In distribution | |
| 15067580 | Outer Diameter 7.5 mm | In distribution |
| 15048595 | Outer Diameter 8.5 mm | In distribution |
| 13026555 | Outer Diameter 6.5 mm | In distribution |
| 18018530 | Length 30 mm | In distribution |
| 18111025 | Length 25 mm | In distribution |
| 18117570 | Length 70 mm | In distribution |
| 15041065 | Outer Diameter 10.5 mm | In distribution |
| 18475542 | Outer Diameter 5.5 mm | In distribution |
| 18118585 | Outer Diameter 8.5 mm | In distribution |
| 18178550 | Length 50 mm | In distribution |
| 13027555 | Outer Diameter 7.5 mm | In distribution |
| 18475507 | Length 70 mm | In distribution |
| 15068535 | Outer Diameter 8.5 mm | In distribution |
| 18157535 | Length 35 mm | In distribution |
| 18912026 | In distribution | |
| 18188585 | Outer Diameter 8.5 mm | In distribution |
| 18046560 | Length 60 mm | In distribution |
| 18744001 | In distribution | |
| 18505085 | Outer Diameter 5.5 mm | In distribution |
| 13024525 | Length 25 mm | In distribution |
| 13038580 | Length 80 mm | In distribution |
| 18017540 | Length 40 mm | In distribution |
| 18016525 | Length 25 mm | In distribution |
| 18169590 | Outer Diameter 9.5 mm | In distribution |
| 18185525 | Length 25 mm | In distribution |
| 13028545 | Outer Diameter 8.5 mm | In distribution |
| 15064535 | Outer Diameter 4.5 mm | In distribution |
| 15067535 | Outer Diameter 7.5 mm | In distribution |
| 18014530 | Length 30 mm | In distribution |
| 18019510 | Length 100 mm | In distribution |
| 15068585 | Outer Diameter 8.5 mm | In distribution |
| 13027565 | Outer Diameter 7.5 mm | In distribution |
| 18037575 | Length 75 mm | In distribution |
| 13028550 | Length 50 mm | In distribution |
| 18475520 | Length 200 mm | In distribution |
| 18011040 | Length 40 mm | In distribution |
| 13028570 | Length 70 mm | In distribution |
| 13029535 | Outer Diameter 9.5 mm | In distribution |
| 18179540 | Length 40 mm | In distribution |
| 18037540 | Length 40 mm | In distribution |
| 18014545 | Length 45 mm | In distribution |
| 18037590 | Length 90 mm | In distribution |
| 18169540 | Outer Diameter 9.5 mm | In distribution |
| 13029550 | Length 50 mm | In distribution |
| 18157545 | Length 45 mm | In distribution |
| 18116555 | Length 55 mm | In distribution |
| 18117595 | Outer Diameter 7.5 mm | In distribution |
| 18535240 | Length 240 mm | In distribution |
| 13495220 | Length 220 mm | In distribution |
| 18178510 | Length 100 mm | In distribution |
| 13021070 | Length 70 mm | In distribution |
| 18039510 | Length 100 mm | In distribution |
| 18046545 | Length 45 mm | In distribution |
| 1505453545 | Outer Diameter 4.5 mm | In distribution |
| 15059510 | Outer Diameter 9.5 mm | In distribution |
| 15051040 | Outer Diameter 10.5 mm | In distribution |
| 18165520 | Outer Diameter 5.5 mm | In distribution |
| 18189535 | Outer Diameter 9.5 mm | In distribution |
| 15041090 | Outer Diameter 10.5 mm | In distribution |
| 18117530 | Length 30 mm | In distribution |
| 13025550 | Outer Diameter 5.5 mm | In distribution |
| 18535440 | Outer Diameter 5.5 mm | In distribution |
| 15045555 | Outer Diameter 5.5 mm | In distribution |
| 15051055 | Outer Diameter 10.5 mm | In distribution |
| 18535260 | Outer Diameter 5.5 mm | In distribution |
| 15054520 | Outer Diameter 4.5 mm | In distribution |
| 18119585 | Outer Diameter 9.5 mm | In distribution |
| 18166550 | Outer Diameter 6.5 mm | In distribution |
| 18161075 | Outer Diameter 10.5 mm | In distribution |
| 15061040 | Outer Diameter 10.5 mm | In distribution |
| 18164525 | Length 25 mm | In distribution |
| 18161060 | Length 60 mm | In distribution |
| 18415595 | Length 85 mm | In distribution |
| 15055545 | Outer Diameter 5.5 mm | In distribution |
| 18167560 | Outer Diameter 7.5 mm | In distribution |
| 18505035 | Length 35 mm | In distribution |
| 15059545 | Outer Diameter 9.5 mm | In distribution |
| 18174540 | Length 40 mm | In distribution |
| 15059540 | Outer Diameter 9.5 mm | In distribution |
| 18016535 | Length 35 mm | In distribution |
| 18415511 | Length 110 mm | In distribution |
| 13018540 | Length 40 mm | In distribution |
| 18169510 | Outer Diameter 9.5 mm | In distribution |
| 18038550 | Length 50 mm | In distribution |
| 13435100 | Outer Diameter 5.5 mm | In distribution |
| 13028555 | Outer Diameter 8.5 mm | In distribution |
| 18016560 | Length 60 mm | In distribution |
| 18535030 | Outer Diameter 5.5 mm | In distribution |
| 13029540 | Length 40 mm | In distribution |
| 15041030 | Outer Diameter 10.5 mm | In distribution |
| 15065535 | Outer Diameter 5.5 mm | In distribution |
| 15067570 | Outer Diameter 7.5 mm | In distribution |
| 18181070 | Length 70 mm | In distribution |
| 13039590 | Length 90 mm | In distribution |
| 18177565 | Outer Diameter 7.5 mm | In distribution |
| 18535220 | Outer Diameter 5.5 mm | In distribution |
| 18475506 | Outer Diameter 5.5 mm | In distribution |
| 15048580 | Outer Diameter 8.5 mm | In distribution |
| 18165535 | Outer Diameter 5.5 mm | In distribution |
| 18037595 | Length 95 mm | In distribution |
| 15055520 | Outer Diameter 5.5 mm | In distribution |
| 18505055 | Outer Diameter 5.5 mm | In distribution |
| 15047550 | Outer Diameter 7.5 mm | In distribution |
| 18044545 | Length 45 mm | In distribution |
| 18187560 | Length 60 mm | In distribution |
| 18178530 | Length 30 mm | In distribution |
| 18181060 | Length 60 mm | In distribution |
| 18177560 | Length 60 mm | In distribution |
| 15058550 | Outer Diameter 8.5 mm | In distribution |
| 18017575 | Length 75 mm | In distribution |
| 18046535 | Length 35 mm | In distribution |
| 15058530 | Outer Diameter 8.5 mm | In distribution |
| 13911012 | In distribution | |
| 15058595 | Outer Diameter 8.5 mm | In distribution |
| 18177510 | Length 100 mm | In distribution |
| 15044520 | Outer Diameter 4.5 mm | In distribution |
| 15059595 | Outer Diameter 9.5 mm | In distribution |
| 15049555 | Outer Diameter 9.5 mm | In distribution |
| 13495160 | Outer Diameter 5.5 mm | In distribution |
| 18442731 | In distribution | |
| 13029585 | Outer Diameter 9.5 mm | In distribution |
| 18046555 | Length 55 mm | In distribution |
| 13027545 | Outer Diameter 7.5 mm | In distribution |
| 13037590 | Length 90 mm | In distribution |
| 18166520 | Outer Diameter 6.5 mm | In distribution |
| 15057510 | Outer Diameter 7.5 mm | In distribution |
| 18415509 | Length 90 mm | In distribution |
| 18161045 | Outer Diameter 10.5 mm | In distribution |
| 15047590 | Outer Diameter 7.5 mm | In distribution |
| 15061090 | Outer Diameter 10.5 mm | In distribution |
| 15056550 | Outer Diameter 6.5 mm | In distribution |
| 18505060 | Length 60 mm | In distribution |
| 18038560 | Length 60 mm | In distribution |
| 18475509 | Length 90 mm | In distribution |
| 18188555 | Outer Diameter 8.5 mm | In distribution |
| 18116525 | Length 25 mm | In distribution |
| 13017530 | Length 30 mm | In distribution |
| 15047525 | Outer Diameter 7.5 mm | In distribution |
| 18167550 | Outer Diameter 7.5 mm | In distribution |
| 15056520 | Outer Diameter 6.5 mm | In distribution |
| 15068575 | Outer Diameter 8.5 mm | In distribution |
| 18156555 | Length 55 mm | In distribution |
| 13016535 | Length 35 mm | In distribution |
| 18620009 | Outer Diameter 9 mm | In distribution |
| 15061080 | Outer Diameter 10.5 mm | In distribution |
| 18045535 | Length 35 mm | In distribution |
| 15047560 | Outer Diameter 7.5 mm | In distribution |
| 15059580 | Outer Diameter 9.5 mm | In distribution |
| 18157575 | Length 75 mm | In distribution |
| 18174535 | Outer Diameter 4.5 mm | In distribution |
| 15048555 | Outer Diameter 8.5 mm | In distribution |
| 18181080 | Length 80 mm | In distribution |
| 15057580 | Outer Diameter 7.5 mm | In distribution |
| 18045545 | Length 40 mm | In distribution |
| 18742000 | In distribution | |
| 18475528 | Length 280 mm | In distribution |
| 13035545 | Length 45 mm | In distribution |
| 13025545 | Length 45 mm | In distribution |
| 18186520 | Length 20 mm | In distribution |
| 15067595 | Outer Diameter 7.5 mm | In distribution |
| 13021050 | Length 50 mm | In distribution |
| 18415535 | Length 35 mm | In distribution |
| 18018540 | Length 40 mm | In distribution |
| 18189565 | Outer Diameter 9.5 mm | In distribution |
| 18178545 | Outer Diameter 8.5 mm | In distribution |
| 15058560 | Outer Diameter 8.5 mm | In distribution |
| 18115545 | Length 45 mm | In distribution |
| 18154540 | Length 40 mm | In distribution |
| 13039530 | Length 30 mm | In distribution |
| 15059585 | Outer Diameter 9.5 mm | In distribution |
| 18038590 | Length 90 mm | In distribution |
| 15059550 | Outer Diameter 9.5 mm | In distribution |
| 15061070 | Outer Diameter 10.5 mm | In distribution |
| 15067540 | Outer Diameter 7.5 mm | In distribution |
| 18178540 | Length 40 mm | In distribution |
| 18455534 | Length 340 mm | In distribution |
| 18911040 | In distribution | |
| 15056555 | Outer Diameter 6.5 mm | In distribution |
| 18151090 | Length 90 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 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 |
|---|---|---|---|---|---|---|---|
| Clariance, Inc. | 510(k) number | 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.