Reform TI Pedicle Screw System
Reform TI Pedicle Screw System is part of a top-loading posterior spinal fixation system with pedicle screws, rods, cross-connectors, locking caps, hooks and offset connectors. Modular…
Reform TI Pedicle Screw System is part of a top-loading posterior spinal fixation system with pedicle screws, rods, cross-connectors, locking caps, hooks and offset connectors. Modular pedicle screws allow assembly by the surgeon during implantation.
The system stabilizes thoracic, lumbar and sacral segments as an adjunct to fusion for specified instabilities or deformities. Component sizes accommodate patient anatomy, and the system includes titanium, titanium alloy, cobalt-chromium and stainless steel options.
Listed Item
Modular Ti Non-Fluted Screw Implant Kit – Std: 5.5 – 7.5 Ply (CoCr Rods)
Patient and Graft Conditions
Adult indications include degenerative disease, trauma, deformity, tumor and failed fusion. Pediatric posterior noncervical fixation is limited to adolescent idiopathic scoliosis and uses autograft or allograft. For severe Grade 3 or 4 L5-S1 spondylolisthesis, implants are removed after solid fusion.
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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K150856 |
| Record published | 2021-06-10 |
| Record revised | 2024-09-11 (version 3) |
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, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 39-HM-9570 | In distribution | |
| 39-SG-7570 | In distribution | |
| 39-SG-6540 | In distribution | |
| 39-SG-8512 | In distribution | |
| 39-SB-4545 | In distribution | |
| 39-SG-8511 | In distribution | |
| 39-HM-1040 | In distribution | |
| 39-SG-9545 | In distribution | |
| 39-SG-8560 | In distribution | |
| 39-SG-5530 | In distribution | |
| 39-SG-8580 | In distribution | |
| 39-HM-1055 | In distribution | |
| 39-SG-5540 | In distribution | |
| 39-SG-4525 | In distribution | |
| 39-TP-1055 | In distribution | |
| 39-SG-9580 | In distribution | |
| 39-HM-1045 | In distribution | |
| 39-SB-4535 | In distribution | |
| 39-SG-7540 | In distribution | |
| 39-SG-5535 | In distribution | |
| 39-SB-9550 | In distribution | |
| 39-SG-9555 | In distribution | |
| 39-BK-0553 | In distribution | |
| 39-SG-1011 | In distribution | |
| 39-SG-7535 | In distribution | |
| 39-SG-9512 | In distribution | |
| 39-SG-6555 | In distribution | |
| 39-HM-1050 | In distribution | |
| 39-SG-9590 | In distribution | |
| 39-SG-1000 | In distribution | |
| 39-BK-0554 | In distribution | |
| 39-SG-4545 | In distribution | |
| 39-SG-9511 | In distribution | |
| 39-SG-7545 | In distribution | |
| 39-SG-6530 | In distribution | |
| 39-SG-1070 | In distribution | |
| 39-HM-9511 | In distribution | |
| 39-SG-9550 | In distribution | |
| 39-SG-5525 | In distribution | |
| 39-SG-8545 | In distribution | |
| 39-SG-8570 | In distribution | |
| 39-SG-1050 | In distribution | |
| 39-HM-9560 | In distribution | |
| 39-SG-9500 | In distribution | |
| 39-HM-1070 | In distribution | |
| 39-SB-9500 | In distribution | |
| 39-SG-5555 | In distribution | |
| 39-SB-5550 | In distribution | |
| 39-SG-1012 | In distribution | |
| 39-SG-8550 | In distribution | |
| 39-SG-7530 | In distribution | |
| 39-SG-9560 | In distribution | |
| 39-SG-8500 | In distribution | |
| 39-HM-1060 | In distribution | |
| 39-SG-4530 | In distribution | |
| 39-SG-4540 | In distribution | |
| 39-SG-9540 | In distribution | |
| 39-HM-9580 | In distribution | |
| 39-HM-1011 | In distribution | |
| 39-SG-1040 | In distribution | |
| 39-SG-8540 | In distribution | |
| 39-SG-8555 | In distribution | |
| 39-SG-5545 | In distribution | |
| 39-SB-5530 | In distribution | |
| 39-SG-1045 | In distribution | |
| 39-HM-9512 | In distribution | |
| 39-HM-9590 | In distribution | |
| 39-SG-1055 | In distribution | |
| 39-SG-1060 | In distribution | |
| 39-SG-6525 | In distribution | |
| 39-SG-7550 | In distribution | |
| 39-SG-8535 | In distribution | |
| 39-SG-1090 | In distribution | |
| 39-SG-9570 | In distribution | |
| 39-BK-0551 | In distribution | |
| 39-SG-6545 | In distribution | |
| 39-SG-7560 | In distribution | |
| 39-HM-9555 | In distribution | |
| 39-SG-1080 | In distribution | |
| 39-SG-4535 | In distribution | |
| 39-SG-5560 | In distribution | |
| 39-SG-5550 | In distribution | |
| 39-SG-6560 | In distribution | |
| 39-BK-0552 | In distribution | |
| 39-HM-9500 | In distribution | |
| 39-SG-6550 | In distribution | |
| 39-SG-8590 | In distribution | |
| 39-SG-7555 | In distribution | |
| 39-SG-7580 | In distribution | |
| 39-SB-6540 | In distribution | |
| 39-SB-5540 | In distribution | |
| 39-SG-6535 | In distribution | |
| 39-SB-5545 | 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 |
|---|---|
| K242297 | 2024-12-17 |
| K200303 | 2020-05-19 |
| K173130 | 2017-12-19 |
| K151422 | 2015-08-21 |
| K150856 | 2015-07-07 |
| K143248 | 2014-12-19 |
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.