Polaris 5.5 TI Spinal System
86 catalogue numbers from 14-578645, 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
86catalogue 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 |
|---|---|---|
| 14-578645 | 5.5 TI 8.5X45MM TRANSLATION | In distribution |
| 14-578595R | 5.5 TI 7.5X95MM TRANS REDUC | In distribution |
| 14-578465R | 5.5 TI 6.5X65MM TRANS REDUC | In distribution |
| 14-578740R | 5.5 TI 9.5X40MM TRANS REDUC | In distribution |
| 14-578750R | 5.5 TI 9.5X50MM TRANS REDUC | In distribution |
| 14-578295R | 5.5 TI 4.75X95MM TRANS REDUC | In distribution |
| 14-578803R | 5.5 TI 10.5X115MM TRANS REDUC | In distribution |
| 14-578745 | 5.5 TI 9.5 X 45MM TRANSLATION | In distribution |
| 14-578770 | 5.5 TI 9.5 X 70MM TRANSLATION | In distribution |
| 14-578390 | 5.5 TI 5.5X90MM TRANSLATION | In distribution |
| 14-510750R | 5.5 TI 7.5X50MM TAPERED REDUC | In distribution |
| 14-578650 | 5.5 TI 8.5X50MM TRANSLATION | In distribution |
| 14-578799 | 5.5 TI 9.5 X 100MM TRANSLATION | In distribution |
| 14-578590 | 5.5 TI 7.5X90MM TRANSLATION | In distribution |
| 14-578206 | 5.5 TI 4.75X130MM TRANSLATION | In distribution |
| 14-578650R | 5.5 TI 8.5X50MM TRANS REDUC | In distribution |
| 14-578750 | 5.5 TI 9.5 X 50MM TRANSLATION | In distribution |
| 14-578703R | 5.5 TI 9.5X115MM TRANS REDUC | In distribution |
| 14-578705 | 5.5 TI 9.5 X 125MM TRANSLATION | In distribution |
| 14-578530R | 5.5 TI 7.5X30MM TRANS REDUC | In distribution |
| 14-578565R | 5.5 TI 7.5X65MM TRANS REDUC | In distribution |
| 14-578735 | 5.5 TI 9.5 X 35MM TRANSLATION | In distribution |
| 14-578402 | 5.5 TI 6.5X110MM TRANSLATION | In distribution |
| 14-578625R | 5.5 TI 8.5X25MM TRANS REDUC | In distribution |
| 14-578375 | 5.5 TI 5.5X75MM TRANSLATION | In distribution |
| 14-578830 | 5.5 TI 10.5 X 30MM TRANSLATION | In distribution |
| 14-578485R | 5.5 TI 6.5X85MM TRANS REDUC | In distribution |
| 14-578345 | 5.5 TI 5.5X45MM TRANSLATION | In distribution |
| 14-578599R | 5.5 TI 7.5X100MM TRANS REDUC | In distribution |
| 14-578501 | 5.5 TI 7.5X105MM TRANSLATION | In distribution |
| 14-578640R | 5.5 TI 8.5X40MM TRANS REDUC | In distribution |
| 14-510635R | 5.5 TI 6.5X35MM TAPERED REDUC | In distribution |
| 14-510735 | 5.5 TI 7.5 X 35MM TAPERED MAS | In distribution |
| 14-578525R | 5.5 TI 7.5X25MM TRANS REDUC | In distribution |
| 14-578799R | 5.5 TI 9.5X100MM TRANS REDUC | In distribution |
| 14-510645 | 5.5 TI 6.5 X 45MM TAPERED MAS | In distribution |
| 14-578320R | 5.5 TI 5.5X20MM TRANS REDUC | In distribution |
| 14-578575 | 5.5 TI 7.5X75MM TRANSLATION | In distribution |
| 14-578805 | 5.5 TI 10.5 X125MM TRANSLATION | In distribution |
| 14-578255 | 5.5 TI 4.75X55MM TRANSLATION | In distribution |
| 14-578430 | 5.5 TI 6.5X30MM TRANSLATION | In distribution |
| 14-510755 | 5.5 TI 7.5 X 55MM TAPERED MAS | In distribution |
| 14-578802 | 5.5 TI 10.5 X110MM TRANSLATION | In distribution |
| 14-578345R | 5.5 TI 5.5X45MM TRANS REDUC | In distribution |
| 14-578307 | 5.5 TI 5.5X135MM TRANSLATION | In distribution |
| 14-578545R | 5.5 TI 7.5X45MM TRANS REDUC | In distribution |
| 14-510760R | 5.5 TI 7.5X60MM TAPERED REDUC | In distribution |
| 14-578425 | 5.5 TI 6.5X25MM TRANSLATION | In distribution |
| 14-578301R | 5.5 TI 5.5X105MM TRANS REDUC | In distribution |
| 14-578408 | 5.5 TI 6.5X140MM TRANSLATION | In distribution |
| 14-578780 | 5.5 TI 9.5 X 80MM TRANSLATION | In distribution |
| 14-510655R | 5.5 TI 6.5X55MM TAPERED REDUC | In distribution |
| 14-578601R | 5.5 TI 8.5X105MM TRANS REDUC | In distribution |
| 14-578702 | 5.5 TI 9.5 X 110MM TRANSLATION | In distribution |
| 14-578470R | 5.5 TI 6.5X70MM TRANS REDUC | In distribution |
| 14-578895 | 5.5 TI 10.5 X 95MM TRANSLATION | In distribution |
| 14-578620 | 5.5 TI 8.5X20MM TRANSLATION | In distribution |
| 14-578355R | 5.5 TI 5.5X55MM TRANS REDUC | In distribution |
| 14-578508R | 5.5 TI 7.5X140MM TRANS REDUC | In distribution |
| 14-578808 | 5.5 TI 10.5 X140MM TRANSLATION | In distribution |
| 14-578706R | 5.5 TI 9.5X130MM TRANS REDUC | In distribution |
| 14-510740 | 5.5 TI 7.5 X 40MM TAPERED MAS | In distribution |
| 14-578475 | 5.5 TI 6.5X75MM TRANSLATION | In distribution |
| 14-578790 | 5.5 TI 9.5 X 90MM TRANSLATION | In distribution |
| 14-578660 | 5.5 TI 8.5X60MM TRANSLATION | In distribution |
| 14-578302R | 5.5 TI 5.5X110MM TRANS REDUC | In distribution |
| 14-578580 | 5.5 TI 7.5X80MM TRANSLATION | In distribution |
| 14-578807 | 5.5 TI 10.5 X135MM TRANSLATION | In distribution |
| 14-578801R | 5.5 TI 10.5X105MM TRANS REDUC | In distribution |
| 14-578601 | 5.5 TI 8.5X105MM TRANSLATION | In distribution |
| 14-578309R | 5.5 TI 5.5X145MM TRANS REDUC | In distribution |
| 14-578406R | 5.5 TI 6.5X130MM TRANS REDUC | In distribution |
| 14-510560 | 5.5 TI 5.5 X 60MM TAPERED MAS | In distribution |
| 14-578305 | 5.5 TI 5.5X125MM TRANSLATION | In distribution |
| 14-578770R | 5.5 TI 9.5X70MM TRANS REDUC | In distribution |
| 14-578275 | 5.5 TI 4.75X75MM TRANSLATION | In distribution |
| 14-510640 | 5.5 TI 6.5 X 40MM TAPERED MAS | In distribution |
| 14-578240 | 5.5 TI 4.75X40MM TRANSLATION | In distribution |
| 14-578405R | 5.5 TI 6.5X125MM TRANS REDUC | In distribution |
| 14-578508 | 5.5 TI 7.5X140MM TRANSLATION | In distribution |
| 14-578460R | 5.5 TI 6.5X60MM TRANS REDUC | In distribution |
| 14-578310R | 5.5 TI 5.5X150MM TRANS REDUC | In distribution |
| 14-578503 | 5.5 TI 7.5X115MM TRANSLATION | In distribution |
| 14-578840R | 5.5 TI 10.5X40MM TRANS REDUC | In distribution |
| 14-578435 | 5.5 TI 6.5X35MM TRANSLATION | In distribution |
| 14-578507 | 5.5 TI 7.5X135MM TRANSLATION | 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.