ClearPoint
ClearPoint System software version 2.2 provides stereotactic guidance for placing and operating instruments or devices during neurological procedures in an MRI environment. The FDA filing…
ClearPoint System software version 2.2 provides stereotactic guidance for placing and operating instruments or devices during neurological procedures in an MRI environment. The FDA filing also describes the system as used with MR imaging.
During planning, the system can identify, label, visualize and quantify segmentable brain structures in loaded MR images. The listed procedures include biopsies and catheter or electrode insertion, including deep brain stimulation lead placement.
Listed Item
SMARTFrame XG 4.5 TwistPoint Kit w/ Wharen Centering Guide and TE
Version 2.2 Software Functions
Version 2.2 integrates ClearPoint Neuro Maestro Brain Model software into the earlier ClearPoint version 2.1 software. The filing describes optional brain structure segmentation, overlays on two-dimensional scans, three-dimensional polygon models and volume measurements.
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) | K233243 |
| Record published | 2023-12-19 |
| Record revised | 2026-04-01 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 40 to 90 °F |
| Distribution end date | 2025-11-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP-WRK-03 | In distribution | |
| NGS-AK-01-11-5 | In distribution | |
| NGS-DS-06 | In distribution | |
| NGS-BM-05 | In distribution | |
| NGS-AK-01-11 | In distribution | |
| NGS-AK-01-11-7 | In distribution | |
| CP-SFW-11-30 | In distribution | |
| CP-NGS-11-TP45-XG-5 | In distribution | |
| CP-WRK-WIN11 | In distribution | |
| NGS-TC-01 | In distribution | |
| CP-NGS-11-SCM-XG | In distribution | |
| CP-NGS-11-CG45-XG | In distribution | |
| CP-NGS-11-TP45-XG | In distribution | |
| CP-NGS-11-SKM-XG | In distribution | |
| CP-WRK-05 | Withdrawn | |
| CP-WRK-04 | Withdrawn | |
| CP-MON-02 | Withdrawn | |
| CP-WRK-02 | Withdrawn | |
| CP-SFW-11-22 | Withdrawn | |
| CP-SFW-11-20 | Withdrawn | |
| CP-NGS-11-TP45-XG-7 | Withdrawn | |
| CP-NGS-11-SKM | Withdrawn | |
| CP-SFW-11-21 | 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.