Excelsiusgps
ExcelsiusGPS Instruments include array sleeve adapters and surgical instruments such as drivers, drills, taps, and probes. The FDA filing says these instruments may be used manually or…
ExcelsiusGPS Instruments include array sleeve adapters and surgical instruments such as drivers, drills, taps, and probes. The FDA filing says these instruments may be used manually or navigated with ExcelsiusGPS or ExcelsiusHub.
The instruments are used to prepare the implant site or implant the device. The filing identifies them as non-sterile and reusable, and states that the submission adds instruments for use with additional spinal screws in conjunction with ExcelsiusGPS or ExcelsiusHub.
Listed Item
RELINE Small Stature Reduction Screwdriver, Outer Sleeve, FH, GPS
Instrument Role
The description is limited to the instruments in this filing, not the navigation systems themselves.
5manufacturers in China registered for this device type
297catalogue numbers in this listing
13510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 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 |
| 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 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K243671 |
| Record published | 2025-07-14 |
| Record revised | 2026-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6252.4201 | In distribution | |
| 6255.0094 | In distribution | |
| 6255.6109 | In distribution | |
| 6255.0017 | In distribution | |
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Showing 250 of 297 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
| Orthopedic Stereotaxic Instrument | Mako Surgical Corp. | 124 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250599 | 2025-11-05 |
| K243814 | 2025-01-10 |
| K243671 | 2024-12-20 |
| K240721 | 2024-06-14 |
| K240568 | 2024-04-29 |
| K233638 | 2024-02-09 |
| K211616 | 2021-08-25 |
| K200047 | 2020-07-10 |
| K191100 | 2019-07-24 |
| K190653 | 2019-04-09 |
| K180690 | 2018-06-25 |
| K171651 | 2017-08-16 |
| K153203 | 2016-02-03 |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2023-12-15 | Class II | Device Design | Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, syste | 570 |
| 2023-12-07 | Class I | Device Design | A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement. | 9 |
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.