Leksell Vantage Stereotactic System
Leksell Vantage provides a coordinate reference for locating brain targets and guiding neurosurgical instruments. A head frame fixes to the skull with disposable pins, maintaining the…
Leksell Vantage provides a coordinate reference for locating brain targets and guiding neurosurgical instruments. A head frame fixes to the skull with disposable pins, maintaining the reference during imaging and treatment.
Its stereotactic arc uses the Leksell center-of-arc principle to direct compatible instruments toward the selected target from different trajectory angles. The frame and arc have complementary fixation and guidance roles.
Listed Item
Leksell Vantage Head Frame Positioning Band
Compatible Instruments and Accessories
Compatible needles, cannulas and electrodes use the required arc interfaces and a 190 mm active working length matching the arc radius. Frame-application and imaging accessories support the setup; a listed head-frame positioning band belongs to this accessory side of the family.
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 | Elekta Instrument AB, Sweden |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K171123 |
| Record published | 2022-12-10 |
| Record revised | 2022-11-14 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 20, pack of 10, pack of 200 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1102873 | In distribution | ||
| 1054768 | In distribution | ||
| 1054774 | In distribution | ||
| 1072928 | In distribution | ||
| 1054956 | In distribution | ||
| 1072929 | In distribution | ||
| 1098532 | In distribution | ||
| 1072922 | In distribution | ||
| 1053704 | In distribution | ||
| 1051632 | In distribution | ||
| 1054958 | In distribution | ||
| 1051800 | In distribution | ||
| 1519675 | FirmFix™ size | In distribution | |
| 1055506 | In distribution | ||
| 1051635 | In distribution | ||
| 1060488 | In distribution | ||
| 1523232 | In distribution | ||
| 1098530 | In distribution | ||
| 1051788 | In distribution | ||
| 1051338 | In distribution | ||
| 1519674 | FirmFix™ size | In distribution | |
| 1055507 | In distribution | ||
| 1055045 | In distribution | ||
| 1055007 | In distribution | ||
| 1072447 | In distribution | ||
| 1053958 | In distribution | ||
| 1536894 | In distribution | ||
| 1055256 | In distribution | ||
| 1055306 | In distribution | ||
| 1527113 | In distribution | ||
| 1551581 | In distribution | ||
| 1098534 | In distribution | ||
| 1054775 | In distribution | ||
| 1072893 | In distribution | ||
| 1519676 | FirmFix™ size | In distribution | |
| 1098528 | In distribution | ||
| 1054773 | In distribution | ||
| 1054253 | In distribution | ||
| 1051631 | In distribution | ||
| 1051796 | In distribution | ||
| 1054879 | In distribution | ||
| 1053930 | In distribution | ||
| 1053444 | 200 | In distribution | |
| 1055515 | In distribution | ||
| 1072931 | In distribution | ||
| 1054250 | In distribution | ||
| 1519677 | FirmFix™ size | In distribution | |
| 1564185 | In distribution | ||
| 1054850 | In distribution | ||
| 1043424 | In distribution | ||
| 1051623 | In distribution | ||
| 1519673 | FirmFix™ size | In distribution | |
| 1054751 | In distribution |
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 |
| Stealth Autoguide™ System | Medtronic Navigation, Inc. | 50 |
| microTargeting™ Insertion Tube | FHC, Inc. | 48 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190887 | 2019-08-01 |
| K171123 | 2017-09-15 |
| K152558 | 2016-03-02 |
| K080355 | 2009-05-01 |
| K080250 | 2008-05-13 |
| K051746 | 2005-07-25 |
| K040979 | 2004-07-23 |
| K033340 | 2004-02-12 |
| K031999 | 2003-07-25 |
| K031980 | 2003-07-25 |
| K013861 | 2001-12-06 |
| K992882 | 1999-09-24 |
| K991636 | 1999-07-20 |
| K973684 | 1998-03-31 |
| K972324 | 1998-03-02 |
| K961639 | 1996-07-26 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Elekta Inc. | 510(k) number | 2026-03-19 | Class II | Device Design | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. | 768 (364Left/364Right) | |
| Elekta Inc. | 510(k) number | 2025-09-30 | Class II | Process change control | Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound | 338 | |
| Elekta Instrument AB | 510(k) number | 2020-06-10 | Class II | Device Design | The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly. | 51 devices | 2024-08-27 |
| Elekta Inc. | 510(k) number | 2020-03-30 | Class II | Process design | A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System. | 25 units. | 2024-04-10 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-09-25 | Class I | Under Investigation by firm | Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on th | 111 kits (666 needles) |
| 2024-03-15 | Class I | Under Investigation by firm | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy ne | 601 needles |
| 2023-03-01 | Class II | Labeling Change Control | The incorrect IFU was distributed with the devices. | 70 devices |
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.