Thoracolumbosacral Pedicle Screw System
The filed PINE pre-bent rod is an implant component of the PINE Pedicle Screw System. This posterior spinal fixation system combines rods with pedicle screws, set screws, connectors, and…
The filed PINE pre-bent rod is an implant component of the PINE Pedicle Screw System. This posterior spinal fixation system combines rods with pedicle screws, set screws, connectors, and transverse links to immobilize and stabilize spinal segments as an adjunct to fusion.
The implant components are titanium alloy, single use, and supplied nonsterile. The system is intended for skeletally mature patients with spinal instability or deformity in the thoracic, lumbar, or sacral spine.
Listed Item
Pine Pre-bent Rod (Sharp Tip) Ø 5.5 x 120 mm
System Testing
The PINE system underwent static compression, dynamic compression, and static torsion testing. These tests evaluated the assembled fixation system in support of its intended use.
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 | TDM Co., Ltd., South Korea |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K220285 |
| Record published | 2022-09-16 |
| Record revised | 2025-07-14 (version 4) |
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, manufacturing date |
| Sizes | Length 25 to 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1523-5120 | Length 120 mm | In distribution |
| 1523-5140 | Length 140 mm | In distribution |
| 1523-5100 | Length 100 mm | In distribution |
| 1523-5160 | Length 160 mm | In distribution |
| 1523-5030 | Length 30 mm | In distribution |
| 1523-5035 | Length 35 mm | In distribution |
| 1523-5200 | Length 200 mm | In distribution |
| 1705-5070 | In distribution | |
| 1705-3442 | In distribution | |
| 1523-5060 | Length 60 mm | In distribution |
| 1054-0001 | In distribution | |
| 1705-3034 | In distribution | |
| 1523-5045 | Length 45 mm | In distribution |
| 1523-5040 | Length 40 mm | In distribution |
| 1523-5180 | Length 180 mm | In distribution |
| 1705-4053 | In distribution | |
| 1523-5025 | Length 25 mm | In distribution |
| 1523-5050 | Length 50 mm | 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 |
|---|---|
| K220285 | 2022-05-19 |
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.