Response 5.5/6.0 Cannulated Screw System
RESPONSE 5.5/6.0 Cannulated Screw System adds guidewire-compatible pedicle screws to the RESPONSE spinal fixation construct. The screws anchor to bone and connect with the previously…
RESPONSE 5.5/6.0 Cannulated Screw System adds guidewire-compatible pedicle screws to the RESPONSE spinal fixation construct. The screws anchor to bone and connect with the previously established rods and connectors to stabilize the posterior, non-cervical spine.
The hollow screws pass over a guidewire during insertion. Cannulated drivers engage their hexalobe interface, and the screw range covers diameters from 6 to 9 mm with lengths varying by diameter.
Listed Item
5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 50mm
Construct and Supply
System implant materials include titanium alloy, cobalt-chromium alloy and commercially pure titanium. Components are supplied nonsterile. The screws are used with the RESPONSE 5.5/6.0 Spine System as an adjunct to fusion in adults and for specified pediatric scoliosis procedures; pediatric fixation is posterior only.
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 | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K222105 |
| Record published | 2023-03-31 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1301-2780 | In distribution | |
| 00-1301-2750 | In distribution | |
| 00-1301-3670 | In distribution | |
| 00-1301-3710 | In distribution | |
| 00-1301-3660 | In distribution | |
| 00-1301-3960 | In distribution | |
| 00-1301-2990 | In distribution | |
| 00-1301-7665 | In distribution | |
| 00-1301-3740 | In distribution | |
| 00-1301-3975 | In distribution | |
| 00-1301-2875 | In distribution | |
| 00-1301-2910 | In distribution | |
| 00-1301-2980 | In distribution | |
| 00-1301-2845 | In distribution | |
| 00-1301-3990 | In distribution | |
| 00-1301-2840 | In distribution | |
| 00-1301-3770 | In distribution | |
| 00-1301-3850 | In distribution | |
| 00-1301-2860 | In distribution | |
| 00-1301-2660 | In distribution | |
| 00-1301-2640 | In distribution | |
| 00-1301-2755 | In distribution | |
| 00-1301-3950 | In distribution | |
| 00-1301-2675 | In distribution | |
| 00-1301-3755 | In distribution | |
| 00-1301-2950 | In distribution | |
| 00-1301-2680 | In distribution | |
| 00-1301-3980 | In distribution | |
| 00-1301-3880 | In distribution | |
| 00-1301-9650 | In distribution | |
| 00-1301-3940 | In distribution | |
| 00-1301-7690 | In distribution | |
| 00-1301-7650 | In distribution | |
| 00-1301-9655 | In distribution | |
| 00-1301-3945 | In distribution | |
| 00-1301-2865 | In distribution | |
| 00-1301-2645 | In distribution | |
| 00-1301-9670 | In distribution | |
| 00-1301-3855 | In distribution | |
| 00-1301-2960 | In distribution | |
| 00-1301-2855 | In distribution | |
| 00-1301-2650 | In distribution | |
| 00-1301-7645 | In distribution | |
| 00-1301-2880 | In distribution | |
| 00-1301-7675 | In distribution | |
| 00-1301-3665 | In distribution | |
| 00-1301-7680 | In distribution | |
| 00-1301-3870 | In distribution | |
| 00-1301-2790 | In distribution | |
| 00-1301-2765 | In distribution | |
| 00-1301-3640 | In distribution | |
| 00-1301-3775 | In distribution | |
| 00-1301-2710 | In distribution | |
| 00-1301-3680 | In distribution | |
| 00-1301-3765 | 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 |
|---|---|
| K222105 | 2023-03-23 |
| K193100 | 2020-03-24 |
| K181390 | 2018-09-18 |
| K160466 | 2016-03-23 |
| K150600 | 2015-05-22 |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2020-07-06 | Class II | Under Investigation by firm | Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device | 73 units | |
| 2015-11-10 | Class II | Process change control | Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw. | 102 | 2016-05-23 |
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.