ClearPoint Array
ClearPoint Array combines MRI-based trajectory planning software with an adjustable frame for guiding neurosurgical tools. The workstation helps the surgeon plan and monitor a path using…
ClearPoint Array combines MRI-based trajectory planning software with an adjustable frame for guiding neurosurgical tools. The workstation helps the surgeon plan and monitor a path using patient MR images.
The frame includes MRI-visible markers and fluid in its targeting stem. The surgeon checks these features on the images, adjusts the frame and confirms alignment before device placement.
Listed Item
ClearPoint Array v1.2.x Neuro Workstation
System Components
The system includes a planning grid, trajectory frame, reducer and guide tubes, accessory kits and a procedure drape. Hardware accessories are supplied sterile for single use, while the workstation comprises a laptop and software. Any preliminary alignment using a separate navigation system must be followed by final alignment and insertion under real-time MR imaging.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Sinovation (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | ClearPoint Neuro Inc., United States |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K202575 |
| Record published | 2021-04-07 |
| Record revised | 2026-04-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-11-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CPA-SFW-11-12 | In distribution | |
| CPA-SFW-11-1 | Withdrawn | |
| CPA-SFW-11-11 | Withdrawn | |
| CPA-WRK-02 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neurological Stereotaxic Instrument | Medtronic Navigation, Inc. | 844 |
| PMT Corporation – Stereotactic | PMT Corp. | 255 |
| Leksell Stereotactic System | Elekta Instrument AB | 199 |
| Neurological Stereotaxic Instrument | Inomed Medizintechnik Gmbh | 146 |
| Neurological Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 125 |
| Geniant Cranial | KOH Young Technology Inc. | 113 |
| CRW® | Integra Lifesciences Corporation | 107 |
| Leksell Stereotactic System | Elekta Solutions AB | 93 |
| microTargeting™ Insertion Tube with Stylet | FHC, Inc. | 60 |
| Leksell Stereotactic System Neurosurgical Instruments | Elekta Instrument AB | 58 |
| Leksell Vantage Stereotactic System | Elekta Instrument AB | 53 |
| Stealth Autoguide™ System | Medtronic Navigation, Inc. | 50 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243657 | 2025-01-24 |
| K233703 | 2024-04-26 |
| K233144 | 2024-01-12 |
| K233141 | 2024-01-12 |
| K233155 | 2024-01-12 |
| K233243 | 2023-11-27 |
| K232102 | 2023-09-15 |
| K222519 | 2022-09-16 |
| K214040 | 2022-04-12 |
| K202575 | 2021-01-22 |
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.