Reform Ti HA Coated Pedicle Screw
The Reform HA-coated pedicle screw is a component of the Reform Pedicle Screw System. The system provides immobilization and stabilization of spinal segments as an adjunct to fusion. The…
The Reform HA-coated pedicle screw is a component of the Reform Pedicle Screw System. The system provides immobilization and stabilization of spinal segments as an adjunct to fusion.
The named addition is a hydroxyapatite coating on the pedicle screws. The system is used for specified non-cervical spinal instability or deformity in skeletally mature patients, including fracture, dislocation, scoliosis, spinal tumor, and failed fusion.
Listed Item
Ø10.5 x 110mm Bone Screw, Cannulated
Pediatric System Use
For pediatric patients, posterior non-cervical fixation is indicated as an adjunct to fusion for adolescent idiopathic scoliosis. The system is intended for use with autograft or allograft.
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) | K151422 |
| Record published | 2022-07-21 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 39-HTC-8550 | In distribution | |
| 39-HTC-6540 | In distribution | |
| 39-HTC-7550 | In distribution | |
| 39-HTC-5550 | In distribution | |
| 39-HTC-8580 | In distribution | |
| 39-HTC-7535 | In distribution | |
| 39-HTC-6560 | In distribution | |
| 39-HTC-1011 | In distribution | |
| 39-HTC-1045 | In distribution | |
| 39-HTC-7580 | In distribution | |
| 39-HTC-9540 | In distribution | |
| 39-HTC-1070 | In distribution | |
| 39-HTC-1000 | In distribution | |
| 39-HTC-1055 | In distribution | |
| 39-HTC-5555 | In distribution | |
| 39-HTC-6555 | In distribution | |
| 39-HTC-5560 | In distribution | |
| 39-HTC-5535 | In distribution | |
| 39-HTC-5545 | In distribution | |
| 39-HTC-5540 | In distribution | |
| 39-HTC-9580 | In distribution | |
| 39-HTC-1080 | In distribution | |
| 39-HTC-9545 | In distribution | |
| 39-HTC-1040 | In distribution | |
| 39-HTC-7570 | In distribution | |
| 39-HTC-9590 | In distribution | |
| 39-HTC-8545 | In distribution | |
| 39-HTC-6525 | In distribution | |
| 39-HTC-7545 | In distribution | |
| 39-HTC-7540 | In distribution | |
| 39-HTC-6550 | In distribution | |
| 39-HTC-6545 | In distribution | |
| 39-HTC-1050 | In distribution | |
| 39-HTC-7530 | In distribution | |
| 39-HTC-8512 | In distribution | |
| 39-HTC-8540 | In distribution | |
| 39-HTC-9512 | In distribution | |
| 39-HTC-5525 | In distribution | |
| 39-HTC-6535 | In distribution | |
| 39-HTC-8560 | In distribution | |
| 39-HTC-7560 | In distribution | |
| 39-HTC-8511 | In distribution | |
| 39-HTC-9550 | In distribution | |
| 39-HTC-8570 | In distribution | |
| 39-HTC-9511 | In distribution | |
| 39-HTC-1012 | In distribution | |
| 39-HTC-5530 | In distribution | |
| 39-HTC-1090 | In distribution | |
| 39-HTC-9570 | In distribution | |
| 39-HTC-7555 | In distribution | |
| 39-HTC-8535 | In distribution | |
| 39-HTC-6530 | In distribution | |
| 39-HTC-9500 | In distribution | |
| 39-HTC-1060 | In distribution | |
| 39-HTC-8590 | In distribution | |
| 39-HTC-8500 | In distribution | |
| 39-HTC-9555 | In distribution | |
| 39-HTC-9560 | In distribution | |
| 39-HTC-8555 | 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.