Lantern ASC
Lantern ASC is a surgical navigation system that helps a surgeon establish alignment axes from anatomical landmarks and instrument positions during knee surgery. It supports implant…
Lantern ASC is a surgical navigation system that helps a surgeon establish alignment axes from anatomical landmarks and instrument positions during knee surgery. It supports implant positioning and ligament balancing in primary or revision total knee arthroplasty.
A palm sized computer module and reference sensor generate positional information. The workflow registers anatomical landmarks, calculates mechanical axes and reference frames, and tracks the relative positioning of surgical instruments.
Listed Item
Lantern ASC Navigation Unit Kit, Knee -CE
System Components
The navigation unit is reusable and nonsterile. A sterile cover and transfer tool allow it to enter the sterile surgical field, while a reference sensor and surgical instruments provide the physical interfaces used during navigation.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Immetech Industrial Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | OrthAlign, Inc., United States |
|---|---|
| FDA product code | ONN |
| Device type | Intraoperative Orthopedic Joint Assessment Aid |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K253507 |
| Record published | 2026-06-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 -22 to 140 °F; Handling environment temperature -22 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 407001-01 | In distribution | |
| 407000-CE | In distribution | |
| 407001-01-CE | In distribution | |
| 407000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Verasense | Orthosensor, Inc. | 140 |
| Lantern | OrthAlign, Inc. | 24 |
| LinkStation Mini | Orthosensor, Inc. | 8 |
| Linkstation Mini Evaluation Kit | Orthosensor, Inc. | 8 |
| Verasense for Stryker Triathlon | Orthosensor, Inc. | 6 |
| Verasense for Zimmer Biomet Persona | Orthosensor, Inc. | 6 |
| eLIBRA® | Synvasive Technology, Inc. | 2 |
| Verasense for Exactech Equinoxe Reverse | Orthosensor, Inc. | 2 |
| Lantern Surgical Assistant | OrthAlign, Inc. | 1 |
| Dongle Assembly | Eventum Orthopaedics Ltd | 1 |
| Quadsense Pro | Eventum Orthopaedics Ltd | 1 |
| Trolly | Eventum Orthopaedics Ltd | 1 |
Showing 12 of 15. All products under Intraoperative Orthopedic Joint Assessment Aid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262253 | 2026-07-31 |
| K253507 | 2026-06-02 |
| K242616 | 2024-10-03 |
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.