Ballista™ Percutaneous
38 catalogue numbers from 14-500685, 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
38catalogue 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 | 2020-06-23 |
| Record revised | 2025-07-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-500685 | 85MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 2000-5255 | 55MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 2000-3640 | 8.5X 40MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3530 | 7.5X 30MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3575 | 7.5X 75MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500665E | 65 MM BALLISTA ROD, SMOOTH | In distribution |
| 2000-3725 | 9.5X 25MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3860 | 10.5X 60MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3799 | 9.5X 100MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3730 | 9.5X 30MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3330 | 5.5X 30MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3760 | 9.5X 60MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3550 | 7.5X 50MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3425 | 6.5X 25MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3520 | 7.5X 20MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3430E | 6.5 X 30 MM CANNULATED SCREW | In distribution |
| 2000-3755 | 9.5X 55MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-5245 | 45MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 2000-3550E | 7.5 X 50 MM CANNULATED SCREW | In distribution |
| 2000-3545E | 7.5 X 45 MM CANNULATED SCREW | In distribution |
| 2000-3495 | 6.5X 95MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-5299 | 100MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 2000-5270 | 70MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 2000-3435 | 6.5X 35MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500480E | 80 MM PERCUTANEOUS ROD, CURVED | In distribution |
| 14-500675 | 75MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 2000-5230 | 30MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 14-500470E | 70 MM PERCUTANEOUS ROD, CURVED | In distribution |
| 2000-3770 | 9.5X 70MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3345 | 5.5X 45MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3620 | 8.5X 20MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3699 | 8.5X 100MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500445E | 45 MM PERCUTANEOUS ROD, CURVED | In distribution |
| 14-500640 | 40MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 2000-3445E | 6.5 X 45 MM CANNULATED SCREW | In distribution |
| 2000-3440E | 6.5 X 40 MM CANNULATED SCREW | In distribution |
| 2000-5260 | 60MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 2000-5265 | 65MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | 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.