Invictus
Invictus MIS Robotic Navigation Reduction Polyaxial Screwdriver, Locking
5manufacturers in China registered for this device type
235catalogue numbers in this listing
7510(k) clearances naming this product code
3recalls 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 | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K153603 |
| Record published | 2023-04-21 |
| Record revised | 2023-09-18 (version 3) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17139-095-N-G | In distribution | |
| 17139-070 | In distribution | |
| 16434-090-N | In distribution | |
| 17833-045-N | In distribution | |
| 16434-075-N | In distribution | |
| 16434-105 | In distribution | |
| 17039-045-N | In distribution | |
| 17085-028 | In distribution | |
| 17139-105 | In distribution | |
| 16434-125-N | In distribution | |
| 16434-100-N | In distribution | |
| 19807-35-N | In distribution | |
| 19808-40-N | In distribution | |
| 17039-115 | In distribution | |
| 16434-085-N | In distribution | |
| 16434-125 | In distribution | |
| 17039-055-N | In distribution | |
| 17085-069 | In distribution | |
| 17039-105 | In distribution | |
| 19808-50-N | In distribution | |
| 17139-085-N | In distribution | |
| 17420 | In distribution | |
| 17833-028-N | In distribution | |
| 17139-060-N-G | In distribution | |
| 17185-059-N | In distribution | |
| 16434-070 | In distribution | |
| 17139-080-N-G | In distribution | |
| 16434-100 | In distribution | |
| 17185-055-N | In distribution | |
| 16421 | In distribution | |
| 16434-045 | In distribution | |
| 17085-031-N | In distribution | |
| 17487-RN | In distribution | |
| 17085-031 | In distribution | |
| 17139-070-N | In distribution | |
| 17488-RN | In distribution | |
| 17139-070-N-G | In distribution | |
| 17833-038-N | In distribution | |
| 17413-35-N | In distribution | |
| 17039-060-N | In distribution | |
| 17039-105-N | In distribution | |
| 17139-060 | In distribution | |
| 17039-090 | In distribution | |
| 17139-075-N | In distribution | |
| 17185-041 | In distribution | |
| 16434-060 | In distribution | |
| 17185-069 | In distribution | |
| 17139-120-N-G | In distribution | |
| 16430 | In distribution | |
| 17139-125-N-G | In distribution | |
| 17166-035-N | In distribution | |
| 17139-085 | In distribution | |
| 17139-110-N-G | In distribution | |
| 17085-045-N | In distribution | |
| 17085-072 | In distribution | |
| 17139-090-N | In distribution | |
| 17139-105-N-G | In distribution | |
| 17039-085-N | In distribution | |
| 17139-075 | In distribution | |
| 17085-055 | In distribution | |
| 17139-065 | In distribution | |
| 17139-115-N | In distribution | |
| 17085-066 | In distribution | |
| 17085-035 | In distribution | |
| 17139-080 | In distribution | |
| 17039-040-N | In distribution | |
| 16434-050 | In distribution | |
| 16434-065 | In distribution | |
| 17039-120 | In distribution | |
| 17060-N | In distribution | |
| 17185-048-N | In distribution | |
| 17139-110 | In distribution | |
| 16434-065-N | In distribution | |
| 17485-RN | In distribution | |
| 16434-120 | In distribution | |
| 17139-100-N-G | In distribution | |
| 17139-065-N-G | In distribution | |
| 19810-N | In distribution | |
| 17139-095-N | In distribution | |
| 17139-050-N-G | In distribution | |
| 17139-065-N | In distribution | |
| 17086 | In distribution | |
| 17185-045 | In distribution | |
| 19807-50-N | In distribution | |
| 17039-100 | In distribution | |
| 17951-N | In distribution | |
| 19807-45-N | In distribution | |
| 17139-115-N-G | In distribution | |
| 17185-069-N | In distribution | |
| 16434-050-N | In distribution | |
| 16434-080-N | In distribution | |
| 17491-RN | In distribution | |
| 17139-100-N | In distribution | |
| 17413-28-N | In distribution | |
| 17185-048 | In distribution | |
| 17039-085 | In distribution | |
| 17139-120-N | In distribution | |
| 17166-040-N | In distribution | |
| 17850-N | In distribution | |
| 16420 | In distribution | |
| 17039-065 | In distribution | |
| 17039-115-N | In distribution | |
| 17185-052 | In distribution | |
| 17085-059 | In distribution | |
| 17833-035-N | In distribution | |
| 17139-045-N-G | In distribution | |
| 17085-041 | In distribution | |
| 17420-01 | In distribution | |
| 17039-070 | In distribution | |
| 17490-RN | In distribution | |
| 17166-050-N | In distribution | |
| 19808-55-N | In distribution | |
| 17421-01 | In distribution | |
| 16434-075 | In distribution | |
| 17139-055-N | In distribution | |
| 17087 | In distribution | |
| 17139-095 | In distribution | |
| 87773-N | In distribution | |
| 17851-N | In distribution | |
| 17185-062 | In distribution | |
| 17085-072-N | In distribution | |
| 17139-050-N | In distribution | |
| 19808-45-N | In distribution | |
| 17139-045-N | In distribution | |
| 17140 | In distribution | |
| 17039-110 | In distribution | |
| 17085-028-N | In distribution | |
| 17039-050-N | In distribution | |
| 16434-090 | In distribution | |
| 17139-105-N | In distribution | |
| 17139-075-N-G | In distribution | |
| 17085-062 | In distribution | |
| 17486-RN | In distribution | |
| 17185-066-N | In distribution | |
| 16431 | In distribution | |
| 16434-085 | In distribution | |
| 17039-040 | In distribution | |
| 17085-038-N | In distribution | |
| 17139-055-N-G | In distribution | |
| 17141 | In distribution | |
| 17085-069-N | In distribution | |
| 16434-110 | In distribution | |
| 17085-052-N | In distribution | |
| 17139-055 | In distribution | |
| 17139-085-N-G | In distribution | |
| 16434-070-N | In distribution | |
| 17139-045 | In distribution | |
| 17139-100 | In distribution | |
| 17039-055 | In distribution | |
| 17039-080 | In distribution | |
| 17039-125 | In distribution | |
| 17085-062-N | In distribution | |
| 17085-048-N | In distribution | |
| 17085-055-N | In distribution | |
| 17139-125 | In distribution | |
| 17139-115 | In distribution | |
| 17039-090-N | In distribution | |
| 17085-048 | In distribution | |
| 16434-080 | In distribution | |
| 17185-062-N | In distribution | |
| 19805-N | In distribution | |
| 17431 | In distribution | |
| 17085-052 | In distribution | |
| 17185-055 | In distribution | |
| 17039-095-N | In distribution | |
| 17185-072 | In distribution | |
| 16434-115-N | In distribution | |
| 17039-120-N | In distribution | |
| 17489-RN | In distribution | |
| 17185-038 | In distribution | |
| 17008 | In distribution | |
| 17039-100-N | In distribution | |
| 17950-N | In distribution | |
| 17085-066-N | In distribution | |
| 17139-050 | In distribution | |
| 17480-RN | In distribution | |
| 16434-115 | In distribution | |
| 16434-045-N | In distribution | |
| 17139-110-N | In distribution | |
| 17088 | In distribution | |
| CI-10509 | In distribution | |
| 17039-075 | In distribution | |
| 17039-050 | In distribution | |
| 17166-045-N | In distribution | |
| 17139-090 | In distribution | |
| 16434-055-N | In distribution | |
| 17185-052-N | In distribution | |
| 17185-045-N | In distribution | |
| 17421 | In distribution | |
| 19807-30-N | In distribution | |
| 17185-066 | In distribution | |
| 17085-041-N | In distribution | |
| 17139-090-N-G | In distribution | |
| 17833-052-N | In distribution | |
| 16434-120-N | In distribution | |
| 17139-080-N | In distribution | |
| 17041 | In distribution | |
| 17484-RN | In distribution | |
| 16434-095-N | In distribution | |
| 17039-125-N | In distribution | |
| 19807-40-N | In distribution | |
| 17833-041-N | In distribution | |
| 17039-075-N | In distribution | |
| 17166-055-N | In distribution | |
| 16434-055 | In distribution | |
| 17139-125-N | In distribution | |
| 17039-045 | In distribution | |
| 16434-105-N | In distribution | |
| 17185-059 | In distribution | |
| 17185-072-N | In distribution | |
| 17085-059-N | In distribution | |
| 17040 | In distribution | |
| 17139-120 | In distribution | |
| 17413-31-N | In distribution | |
| 17089 | In distribution | |
| 17039-070-N | In distribution | |
| 17185-041-N | In distribution | |
| 17413-38-N | In distribution | |
| 17085-038 | In distribution | |
| 17039-110-N | In distribution | |
| 17039-060 | In distribution | |
| 17039-095 | In distribution | |
| 17039-065-N | In distribution | |
| 16434-060-N | In distribution | |
| 17833-048-N | In distribution | |
| 17039-080-N | In distribution | |
| 17007-N | In distribution | |
| 17430 | In distribution | |
| 17139-060-N | In distribution | |
| 16434-095 | In distribution | |
| 17185-038-N | In distribution | |
| 17085-045 | In distribution | |
| 16434-110-N | In distribution | |
| 17833-031-N | In distribution | |
| 17085-035-N | In distribution |
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 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| 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 |
|---|---|
| K252597 | 2026-02-19 |
| K240951 | 2024-06-06 |
| K232345 | 2023-11-02 |
| K232044 | 2023-10-06 |
| K232413 | 2023-09-08 |
| K223765 | 2023-03-23 |
| K153603 | 2016-04-29 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-01-02 | Class II | Device Design | Due a design issue where the navigated array connection geometry is incorrect. | 7 units |
| 2026-01-02 | Class II | Device Design | Due a design issue where the navigated array connection geometry is incorrect. | 15 units |
| 2022-09-14 | Class II | No Marketing Application | Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing. | 42 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.