Spine System
33 catalogue numbers from 14-575613, 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
33catalogue 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 7) |
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 |
|---|---|---|
| 14-575613 | WASHER ANTERIOR, SST POLARIS SMALL | In distribution |
| 14-501153 | LEFT ANGLED HOOK, SMALL | In distribution |
| 14-501161 | WIDE LAMINAR HOOK, LARGE | In distribution |
| LV01374 | Z-Connect Inserter – Short | In distribution |
| 14-501169 | LEFT OFFSET HOOK, MEDIUM | In distribution |
| 14-501162 | NARROW LAMINAR HOOK, SMALL | In distribution |
| 14-501177 | EXTENDED LAMINAR HOOK, SMALL | In distribution |
| 14-501302 | 7.5MM(D) X 20MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| LV01486 | 30mm Pilot Drill Depth Stop | In distribution |
| 14-501292 | 6.5MM(D) X 70MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-575120 | LATERAL CONNECTOR, OPEN, 25MM 6.35 SST COMPONENT | In distribution |
| 14-501307 | 7.5MM(D) X 45MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 14-500779 | DOMINO, SS 4.75MMX6.35MM AXIAL | In distribution |
| LV01489 | 45mm Pilot Drill Depth Stop | In distribution |
| 14-501334 | 8.5MM(D) X 80MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| LV01485 | 25mm Pilot Drill Depth Stop | In distribution |
| LV01488 | 40mm Pilot Drill Depth Stop | In distribution |
| 14-501174 | ANGLED BLADE HOOK, SMALL | In distribution |
| 14-501314 | 7.5MM(D) X 80MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-500783 | 6.0MM X 6.0MM AXIAL SST DOMINO | In distribution |
| LV01369 | Z-Connect Inserter | In distribution |
| 14-501160 | WIDE LAMINAR HOOK, MEDIUM | In distribution |
| 14-501326 | 8.5MM(D) X 40MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 14-500782 | DOMINO, SS 5.5MM X 6.35MM AXIAL | In distribution |
| 14-575122 | LATERAL CONNECTOR, OPEN, 35MM 6.35 SST | In distribution |
| 14-500772 | 4.5MM X 4.75MM AXIAL SST DOMINO | In distribution |
| 14-575126 | LATERAL CONNECTOR, OPEN, 75MM 6.35 SST | In distribution |
| 14-501179 | EXTENDED LAMINAR HOOK, LARGE | In distribution |
| 14-501166 | NARROW REDUCED LAMINAR HOOK MEDIUM | In distribution |
| 14-501331 | 8.5MM(D) X 65MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-501309 | 7.5MM(D) X 55MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 14-501315 | 7.5MM(D) X 85MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-501313 | 7.5MM(D) X 75MM(L) MULTIAXIAL ILIAC SCREW (6.35) | 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.