Lotus
Ø4.0mm X 26mm Polyaxial Screw 8mm Smooth Shank
15manufacturers in China registered for this device type
3catalogue numbers in this listing
11510(k) clearances naming this product code
22recalls on this 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 | Spinal Elements, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-03-05 |
| Record revised | 2025-07-02 (version 6) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32508-026 | In distribution | |
| 32314-009 | In distribution | |
| 32365-000 | 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 |
|---|---|
| K243916 | 2025-02-21 |
| K222516 | 2022-12-01 |
| K191576 | 2019-09-16 |
| K172967 | 2018-04-10 |
| K151215 | 2015-06-03 |
| K141372 | 2014-08-22 |
| K120467 | 2012-07-30 |
| K091587 | 2009-07-01 |
| K082353 | 2009-01-22 |
| K083230 | 2008-12-03 |
| K071914 | 2007-10-12 |
Recalls
22 of these are 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 |
|---|---|---|---|---|---|
| 2015-04-09 | Class III | Under Investigation by firm | Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marki | 588 | 2015-06-25 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
| 2009-04-17 | Class III | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | 68 units total | 2013-05-07 |
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.