Dark Star Deformity
Dark Star Deformity is a posterior spinal fixation system combining pedicle screws, rods, hooks, connectors and crosslinks. The components assemble into a construct that immobilizes spinal…
Dark Star Deformity is a posterior spinal fixation system combining pedicle screws, rods, hooks, connectors and crosslinks. The components assemble into a construct that immobilizes spinal segments while fusion develops.
The implant range includes titanium alloy and cobalt-chromium components in different sizes. Rods and connectors form the links between the bone anchors, while set screws secure the rod connections.
Listed Item
Republic Spine Straight Hex-end Cobalt Chromium Rod – Ø6.0mm x 500mm
Deformity Configurations
The range includes pre-bent rods, uniplanar screw designs and additional hook and connector options. Separate instruments support delivery and removal of the implants. The implant components are supplied nonsterile for single use.
15manufacturers in China registered for this device type
299catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Republic Spine, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K223096 |
| Record published | 2024-06-21 |
| Record revised | 2025-03-21 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 25 to 600 mm; outer diameter 4 to 10.5 mm |
| Distribution end date | 2024-06-13 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101140-10540 | Outer Diameter 10.5 mm | In distribution |
| 101140-6050 | Length 50 mm | In distribution |
| 100005-7535 | 7.5mm diameter | In distribution |
| 100005-5550 | 5.5mm diameter | In distribution |
| 100008-75100 | Length 100 mm | In distribution |
| 101140-6055 | Length 55 mm | In distribution |
| 100254 | In distribution | |
| 101114-C-7570 | Outer Diameter 7.5 mm | In distribution |
| 100008-6555 | Length 55 mm | In distribution |
| 101140-5045 | Length 45 mm | In distribution |
| 101140-5555 | Length 55 mm | In distribution |
| 101140-9560 | Outer Diameter 9.5 mm | In distribution |
| 101114-C-5025 | Outer Diameter 5.0 mm | In distribution |
| 101114-C-7545 | Outer Diameter 7.5 mm | In distribution |
| 101140-5540 | Length 40 mm | In distribution |
| 100008-7580 | Length 80 mm | In distribution |
| 101140-7540 | Outer Diameter 7.5 mm | In distribution |
| 101140-5550 | Length 50 mm | In distribution |
| 101114-C-8570 | Outer Diameter 8.5 mm | In distribution |
| 101114-C-7590 | Outer Diameter 7.5 mm | In distribution |
| 100005-8555 | Length 55 mm | In distribution |
| 101211-325 | Length 325 mm | In distribution |
| 101139-9580 | Length 80 mm | In distribution |
| 101140-6580 | Length 80 mm | In distribution |
| 100005-85100 | Outer Diameter 8.5 mm | In distribution |
| 100005-6545 | 6.5mm diameter | In distribution |
| 101114-C-6590 | Outer Diameter 6.5 mm | In distribution |
| 100040 | In distribution | |
| 100008-6570 | Length 70 mm | In distribution |
| 101139-10530 | Length 30 mm | In distribution |
| 100008-6545 | Length 45 mm | In distribution |
| 101139-5540 | Length 40 mm | In distribution |
| 100008-75110 | Length 110 mm | In distribution |
| 101139-7535 | Length 35 mm | In distribution |
| 101140-6570 | Length 70 mm | In distribution |
| 101114-C-85100 | Outer Diameter 8.5 mm | In distribution |
| 100005-8530 | Length 50 mm | In distribution |
| 101140-75110 | Outer Diameter 7.5 mm | In distribution |
| 101140-9570 | Outer Diameter 9.5 mm | In distribution |
| 100005-4525 | Length 25 mm | In distribution |
| 101140-9540 | Outer Diameter 9.5 mm | In distribution |
| 101140-7545 | Outer Diameter 7.5 mm | In distribution |
| 101139-8580 | Length 80 mm | In distribution |
| 100276 | In distribution | |
| 101139-6590 | Length 90 mm | In distribution |
| 100008-7535 | 7.5mm diameter | In distribution |
| 101191-60 | Outer Diameter 6.0 mm | In distribution |
| 101140-8550 | Outer Diameter 8.5 mm | In distribution |
| 100008-65100 | Length 100 mm | In distribution |
| 101140-8580 | Outer Diameter 8.5 mm | In distribution |
| 100005-8590 | Outer Diameter 8.5 mm | In distribution |
| 101140-9530 | Outer Diameter 9.5 mm | In distribution |
| 100008-8590 | Length 90 mm | In distribution |
| 101139-7540 | Length 40 mm | In distribution |
| 101114-C-8535 | Outer Diameter 8.5 mm | In distribution |
| 101140-8570 | Outer Diameter 8.5 mm | In distribution |
| 101139-10560 | Length 60 mm | In distribution |
| 100008-6540 | 6.5mm diameter | In distribution |
| 101140-6060 | Length 60 mm | In distribution |
| 100008-4530 | Length 30 mm | In distribution |
| 101139-10550 | Length 50 mm | In distribution |
| 101140-10570 | Outer Diameter 10.5 mm | In distribution |
| 101140-10530 | Outer Diameter 10.5 mm | In distribution |
| 100008-4535 | Outer Diameter 4.5 mm | In distribution |
| 101139-7580 | Length 80 mm | In distribution |
| 101114-C-6530 | Outer Diameter 6.5 mm | In distribution |
| 101140-6540 | Length 40 mm | In distribution |
| 101140-105110 | Outer Diameter 10.5 mm | In distribution |
| 101139-95110 | Length 110 mm | In distribution |
| 101139-65100 | Length 100 mm | In distribution |
| 101140-7580 | Outer Diameter 7.5 mm | In distribution |
| 101139-5030 | Length 30 mm | In distribution |
| 100005-75110 | Length 110 mm | In distribution |
| 101139-6035 | Length 35 mm | In distribution |
| 101140-5035 | Length 35 mm | In distribution |
| 101139-8540 | Length 40 mm | In distribution |
| 100008-7545 | 7.5mm diameter | In distribution |
| 101139-6055 | Length 55 mm | In distribution |
| 101114-C-8590 | Outer Diameter 8.5 mm | In distribution |
| 101212-500 | Outer Diameter 6.0 mm | In distribution |
| 101139-6530 | Length 30 mm | In distribution |
| 101114-C-8545 | Outer Diameter 8.5 mm | In distribution |
| 100005-6540 | Length 40 mm | In distribution |
| 100008-85100 | Length 100 mm | In distribution |
| 100005-65100 | Outer Diameter 6.5 mm | In distribution |
| 100008-4525 | Length 25 mm | In distribution |
| 101200 | In distribution | |
| 100267 | In distribution | |
| 100008-7540 | Length 40 mm | In distribution |
| 100008-7570 | Length 70 mm | In distribution |
| 101139-6060 | Length 60 mm | In distribution |
| 100008-5540 | Length 40 mm | In distribution |
| 100008-5530 | Length 30 mm | In distribution |
| 100005-8570 | Outer Diameter 8.5 mm | In distribution |
| 100020-075 | Outer Diameter 5.5 mm | In distribution |
| 100008-6580 | Length 80 mm | In distribution |
| 101140-6560 | Length 60 mm | In distribution |
| 101140-9550 | Outer Diameter 9.5 mm | In distribution |
| 101114-C-6045 | Outer Diameter 6.0 mm | In distribution |
| 101139-85110 | Length 110 mm | In distribution |
| 101140-75100 | Outer Diameter 7.5 mm | In distribution |
| 100005-8560 | 8.5mm diameter | In distribution |
| 101114-C-75110 | Outer Diameter 7.5 mm | In distribution |
| 101191-55 | Outer Diameter 5.5 mm | In distribution |
| 100005-6590 | Outer Diameter 6.5 mm | In distribution |
| 101114-C-6545 | Outer Diameter 6.5 mm | In distribution |
| 100008-6535 | Length 35 mm | In distribution |
| 101139-75100 | Length 100 mm | In distribution |
| 101139-9545 | Length 45 mm | In distribution |
| 101114-C-7540 | Outer Diameter 7.5 mm | In distribution |
| 101140-5545 | Length 45 mm | In distribution |
| 101140-10560 | Outer Diameter 10.5 mm | In distribution |
| 101140-6045 | Length 45 mm | In distribution |
| 100002 | In distribution | |
| 101114-C-6555 | Outer Diameter 6.5 mm | In distribution |
| 101114-C-7550 | Outer Diameter 7.5 mm | In distribution |
| 101114-C-7530 | Outer Diameter 7.5 mm | In distribution |
| 101114-C-6580 | Outer Diameter 6.5 mm | In distribution |
| 101140-7555 | Outer Diameter 7.5 mm | In distribution |
| 101139-6545 | Length 45 mm | In distribution |
| 101139-5025 | Length 25 mm | In distribution |
| 101212-600 | Outer Diameter 6.0 mm | In distribution |
| 100005-6555 | 6.5mm diameter | In distribution |
| 101139-5560 | Length 60 mm | In distribution |
| 100008-5545 | 5.5mm diameter | In distribution |
| 101114-C-5030 | Outer Diameter 5.0 mm | In distribution |
| 101140-7530 | Length 30 mm | In distribution |
| 101114-C-8530 | Outer Diameter 8.5 mm | In distribution |
| 101139-7545 | Length 45 mm | In distribution |
| 101114-C-5550 | Outer Diameter 5.5 mm | In distribution |
| 101140-5560 | Length 60 mm | In distribution |
| 100008-6530 | 6.5mm diameter | In distribution |
| 100005-7530 | Length 30 mm | In distribution |
| 101191-75 | Outer Diameter 7.5 mm | In distribution |
| 101114-C-6540 | Outer Diameter 6.5 mm | In distribution |
| 101140-8545 | Outer Diameter 8.5 mm | In distribution |
| 101139-9560 | Length 60 mm | In distribution |
| 101140-5025 | Length 25 mm | In distribution |
| 100008-4540 | Outer Diameter 4.5 mm | In distribution |
| 101139-10580 | Length 80 mm | In distribution |
| 101139-6040 | Length 40 mm | In distribution |
| 101140-6590 | Length 90 mm | In distribution |
| 101212-400 | Outer Diameter 6.0 mm | In distribution |
| 101139-7550 | Length 50 mm | In distribution |
| 101139-105100 | Length 100 mm | In distribution |
| 101139-5035 | Length 35 mm | In distribution |
| 101139-7555 | Length 55 mm | In distribution |
| 101139-8560 | Length 60 mm | In distribution |
| 100008-6560 | 6.5mm diameter | In distribution |
| 101114-C-8550 | Outer Diameter 8.5 mm | In distribution |
| 101140-8560 | Outer Diameter 8.5 mm | In distribution |
| 101140-8535 | Outer Diameter 8.5 mm | In distribution |
| 101139-6580 | Length 80 mm | In distribution |
| 101191-50 | Outer Diameter 5.0 mm | In distribution |
| 100008-7560 | Length 60 mm | In distribution |
| 101139-6560 | Length 60 mm | In distribution |
| 101139-5545 | Length 45 mm | In distribution |
| 100008-5550 | Length 50 mm | In distribution |
| 101139-7590 | Length 90 mm | In distribution |
| 101140-6545 | Length 45 mm | In distribution |
| 101139-6540 | Length 40 mm | In distribution |
| 101114-C-85110 | Outer Diameter 8.5 mm | In distribution |
| 101139-10555 | Length 55 mm | In distribution |
| 100005-7580 | Length 80 mm | In distribution |
| 100005-6560 | Outer Diameter 6.5 mm | In distribution |
| 101114-C-6050 | Outer Diameter 6.0 mm | In distribution |
| 101139-5040 | Length 40 mm | In distribution |
| 101140-9555 | Outer Diameter 9.5 mm | In distribution |
| 101139-8530 | Length 30 mm | In distribution |
| 100005-85110 | Outer Diameter 8.5 mm | In distribution |
| 101211-500 | Outer Diameter 6.0 mm | In distribution |
| 101191-85 | Outer Diameter 8.5 mm | In distribution |
| 101140-85110 | Outer Diameter 8.5 mm | In distribution |
| 101140-9535 | Outer Diameter 9.5 mm | In distribution |
| 100008-7590 | Length 90 mm | In distribution |
| 101114-C-5035 | Outer Diameter 5.0 mm | In distribution |
| 100008-7530 | Length 30 mm | In distribution |
| 101140-95110 | Outer Diameter 9.5 mm | In distribution |
| 101139-6535 | Length 35 mm | In distribution |
| 101140-10555 | Outer Diameter 10.5 mm | In distribution |
| 101140-6530 | Length 30 mm | In distribution |
| 101114-C-5045 | Outer Diameter 5.0 mm | In distribution |
| 101139-8570 | Length 70 mm | In distribution |
| 101140-5535 | Length 35 mm | In distribution |
| 101114-C-6030 | Outer Diameter 6.0 mm | In distribution |
| 101140-6040 | Length 40 mm | In distribution |
| 101139-5045 | Length 45 mm | In distribution |
| 101139-5550 | Length 50 mm | In distribution |
| 101139-8545 | Length 45 mm | In distribution |
| 101114-C-7580 | Outer Diameter 7.5 mm | In distribution |
| 101140-7590 | Outer Diameter 7.5 mm | In distribution |
| 101139-6050 | Length 50 mm | In distribution |
| 101140-9590 | Outer Diameter 9.5 mm | In distribution |
| 101140-8590 | Outer Diameter 8.5 mm | In distribution |
| 101140-7535 | Outer Diameter 7.5 mm | In distribution |
| 101140-5040 | Length 40 mm | In distribution |
| 101199 | In distribution | |
| 100008-6550 | 6.5mm diameter | In distribution |
| 100005-8545 | Length 45 mm | In distribution |
| 101114-C-6060 | Outer Diameter 6.0 mm | In distribution |
| 101140-6030 | Length 30 mm | In distribution |
| 101140-9580 | Outer Diameter 9.5 mm | In distribution |
| 100005-5540 | Length 40 mm | In distribution |
| 101139-8555 | Length 55 mm | In distribution |
| 101114-C-5555 | Outer Diameter 5.5 mm | In distribution |
| 101139-5535 | Length 35 mm | In distribution |
| 100008-8570 | Length 70 mm | In distribution |
| 101211-400 | Outer Diameter 6.0 mm | In distribution |
| 101139-9555 | Length 55 mm | In distribution |
| 101114-C-5540 | Outer Diameter 5.5 mm | In distribution |
| 101139-105110 | Length 110 mm | In distribution |
| 101114-C-8555 | Outer Diameter 8.5 mm | In distribution |
| 101114-C-7535 | Outer Diameter 7.5 mm | In distribution |
| 101139-85100 | Length 100 mm | In distribution |
| 101139-6570 | Length 70 mm | In distribution |
| 101140-95100 | Outer Diameter 9.5 mm | In distribution |
| 101140-6535 | Length 35 mm | In distribution |
| 101139-8550 | Length 50 mm | In distribution |
| 101140-6035 | Length 35 mm | In distribution |
| 101139-7570 | Length 70 mm | In distribution |
| 101114-C-5040 | Outer Diameter 5.0 mm | In distribution |
| 101140-6555 | Length 55 mm | In distribution |
| 101139-9590 | Length 90 mm | In distribution |
| 101140-6550 | Length 50 mm | In distribution |
| 101139-8590 | Length 90 mm | In distribution |
| 101114-C-5545 | Outer Diameter 5.5 mm | In distribution |
| 101140-7550 | Outer Diameter 7.5 mm | In distribution |
| 101114-C-8560 | Outer Diameter 8.5 mm | In distribution |
| 101114-C-5560 | Outer Diameter 5.5 mm | In distribution |
| 101114-C-65100 | Outer Diameter 6.5 mm | In distribution |
| 101139-10590 | Length 90 mm | In distribution |
| 101139-6550 | Length 50 mm | In distribution |
| 101139-5530 | Length 30 mm | In distribution |
| 101140-65100 | Length 100 mm | In distribution |
| 101139-95100 | Length 100 mm | In distribution |
| 100008-6590 | Length 90 mm | In distribution |
| 101139-9570 | Length 70 mm | In distribution |
| 101140-8555 | Outer Diameter 8.5 mm | In distribution |
| 101140-7560 | Outer Diameter 7.5 mm | In distribution |
| 101140-10580 | Outer Diameter 10.5 mm | In distribution |
| 100008-85110 | Length 100 mm | In distribution |
| 101140-8530 | Outer Diameter 8.5 mm | In distribution |
| 101139-10535 | Length 35 mm | In distribution |
| 101114-C-8580 | Outer Diameter 8.5 mm | In distribution |
| 101140-9545 | Outer Diameter 9.5 mm | In distribution |
| 100005-7545 | 7.5mm diameter | In distribution |
| 100005-5530 | Length 30 mm | In distribution |
| 101139-10545 | Length 45 mm | In distribution |
| 101114-C-7560 | Outer Diameter 7.5 mm | In distribution |
| 101140-7570 | Outer Diameter 7.5 mm | In distribution |
Showing 250 of 299 catalogue numbers.
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 |
|---|---|
| K223096 | 2023-05-26 |
| K201420 | 2021-03-05 |
| K181495 | 2018-07-25 |
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.