Polaris 6.35 TI Spinal System
65 catalogue numbers from 14-515845, listed by Biomet Spine, United States, under Thoracolumbosacral Pedicle Screw System. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
65catalogue numbers in this listing
5510(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 | Biomet Spine, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2015-10-24 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-515845 | 6.35 TI 10.5X45MM MAS REDUC | In distribution |
| 14-513560R | 7.5MM X 60MM REDUCTION | In distribution |
| 14-515899 | 6.35 TI 10.5X100MM MAS REDUC | In distribution |
| 14-513845R | 10.5MM X 45MM REDUCTION | In distribution |
| 14-515590 | 6.35 TI 7.5X90MM MAS REDUC | In distribution |
| 14-513740R | 9.5MM X 40MM REDUCTION | In distribution |
| 14-513820R | 10.5MM X 20MM REDUCTION | In distribution |
| 14-515365 | 6.35 TI 5.5X65MM MAS REDUC | In distribution |
| 14-513665R | 8.5MM X 65MM REDUCTION | In distribution |
| 14-515320 | 6.35 TI 5.5X20MM MAS REDUC | In distribution |
| 14-513760R | 9.5MM X 60MM REDUCTION | In distribution |
| 14-515670 | 6.35 TI 8.5X70MM MAS REDUC | In distribution |
| 14-515770 | 6.35 TI 9.5X70MM MAS REDUC | In distribution |
| 14-513680R | 8.5MM X 80MM REDUCTION | In distribution |
| 14-513175R | 4.0MM X 75MM REDUCTION | In distribution |
| 14-515450 | 6.35 TI 6.5X50MM MAS REDUC | In distribution |
| 14-515835 | 6.35 TI 10.5X35MM MAS REDUC | In distribution |
| 14-515799 | 6.35 TI 9.5X100MM MAS REDUC | In distribution |
| 14-513855R | 10.5MM X 55MM REDUCTION | In distribution |
| 14-515250 | 6.35 TI 4.75X50MM MAS REDUC | In distribution |
| 14-515230 | 6.35 TI 4.75X30MM MAS REDUC | In distribution |
| 14-515485 | 6.35 TI 6.5X85MM MAS REDUC | In distribution |
| 14-513320R | 5.5MM X 20MM REDUCTION | In distribution |
| 14-515265 | 6.35 TI 4.75X65MM MAS REDUC | In distribution |
| 14-515665 | 6.35 TI 8.5X65MM MAS REDUC | In distribution |
| 14-515399 | 6.35 TI 5.5X100MM MAS REDUC | In distribution |
| 14-515270 | 6.35 TI 4.75X70MM MAS REDUC | In distribution |
| 14-513355R | 5.5MM X 55MM REDUCTION | In distribution |
| 14-513899R | 10.5MM X 100MM REDUCTION | In distribution |
| 14-515640 | 6.35 TI 8.5X40MM MAS REDUC | In distribution |
| 14-515290 | 6.35 TI 4.75X90MM MAS REDUC | In distribution |
| 14-513265R | 4.75MM X 65MM REDUCTION | In distribution |
| 14-513270R | 4.75MM X 70MM REDUCTION | In distribution |
| 14-513135R | 4.0MM X 35MM REDUCTION | In distribution |
| 14-513850R | 10.5MM X 50MM REDUCTION | In distribution |
| 14-513655R | 8.5MM X 55MM REDUCTION | In distribution |
| 14-515355 | 6.35 TI 5.5X55MM MAS REDUC | In distribution |
| 14-515580 | 6.35 TI 7.5X80MM MAS REDUC | In distribution |
| 14-513795R | 9.5MM X 95MM REDUCTION | In distribution |
| 14-515490 | 6.35 TI 6.5X90MM MAS REDUC | In distribution |
| 14-515499 | 6.35 TI 6.5X100MM MAS REDUC | In distribution |
| 14-513595R | 7.5MM X 95MM REDUCTION | In distribution |
| 14-513285R | 4.75MM X 85MM REDUCTION | In distribution |
| 14-513580R | 7.5MM X 80MM REDUCTION | In distribution |
| 14-515850 | 6.35 TI 10.5X50MM MAS REDUC | In distribution |
| 14-515375 | 6.35 TI 5.5X75MM MAS REDUC | In distribution |
| 14-513645R | 8.5MM X 45MM REDUCTION | In distribution |
| 14-515699 | 6.35 TI 8.5X100MM MAS REDUC | In distribution |
| 14-513330R | 5.5MM X 30MM REDUCTION | In distribution |
| 14-513280R | 4.75MM X 80MM REDUCTION | In distribution |
| 14-513830R | 10.5MM X 30MM REDUCTION | In distribution |
| 14-513585R | 7.5MM X 85MM REDUCTION | In distribution |
| 14-513220R | 4.75MM X 20MM REDUCTION | In distribution |
| 14-515860 | 6.35 TI 10.5X60MM MAS REDUC | In distribution |
| 14-515275 | 6.35 TI 4.75X75MM MAS REDUC | In distribution |
| 14-513120R | 4.0MM X 20MM REDUCTION | In distribution |
| 14-513345R | 5.5MM X 45MM REDUCTION | In distribution |
| 14-513399R | 5.5MM X 100MM REDUCTION | In distribution |
| 14-515585 | 6.35 TI 7.5X85MM MAS REDUC | In distribution |
| 14-513725R | 9.5MM X 25MM REDUCTION | In distribution |
| 14-515775 | 6.35 TI 9.5X75MM MAS REDUC | In distribution |
| 14-515345 | 6.35 TI 5.5X45MM MAS REDUC | In distribution |
| 14-513530R | 7.5MM X 30MM REDUCTION | In distribution |
| 14-515220 | 6.35 TI 4.75X20MM MAS REDUC | In distribution |
| 14-515545 | 6.35 TI 7.5X45MM MAS REDUC | 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 |
|---|---|
| K151974 | 2015-11-13 |
| K141804 | 2014-09-25 |
| K121130 | 2012-06-15 |
| K091067 | 2009-07-14 |
| K081952 | 2008-10-07 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-03-12 | Class II | Nonconforming Material/Component | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. | 4,765 units | 2015-12-21 |
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.