Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
FDA 510(k) K262253 · Orthalign, Inc.
510(k) numberK262253
Submission
- Device name
- Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
- Applicant
- Orthalign, Inc.
Irvine, CA, US - Received
- July 2, 2026
- Decision date
- July 31, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ONN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeONN · Traditional | Orthalign, Inc. | 06/02/2026SE |
| K252524 | Quadsense (Quadsense and Quadsense Pro)ONN · Special | Eventum Orthopaedics, Ltd. | 09/09/2025SE |
| K241298 | QuadsenseONN · Traditional | Eventum Orthopaedics, Ltd. | 10/04/2024SE |
| K242616 | Lantern® HipONN · Special | Orthalign, Inc. | 10/03/2024SE |
| K220830 | TrueBalance Surgical SystemONN · Traditional | These Three Medical, LLC | 09/15/2022SE |
| K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm…ONN · Traditional | Orthosensor, Inc. | 08/25/2020SE |
| K200665 | VERASENSE for Stryker TriathlonONN · Special | Orthosensor, Inc. | 04/12/2020SE |
| K193580 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…ONN · Traditional | Orthosensor, Inc. | 04/01/2020SE |
| K180459 | VERASENSE for Zimmer Biomet PersonaONN · Traditional | Orthosensor, Inc. | 06/07/2018SE |
| K162237 | XO1 Knee Balancing SystemONN · Traditional | Xpandortho, Inc. | 04/25/2017SE |
More from Xpandortho, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeONN · Traditional | 06/02/2026SE |
| K242616 | Lantern® HipONN · Special | 10/03/2024SE |
| K200892 | Harvey(R) Surgical AssistantOLO · Special | 06/18/2020SE |
| K200642 | OrthAlign Plus SystemOLO · Special | 04/10/2020SE |
| K172462 | OrthAlign Plus SystemOLO · Traditional | 11/22/2017SE |
| K171780 | OrthAlign Plus SystemOLO · Special | 07/11/2017SE |
| K163379 | KneeAlign 2 SystemOLO · Traditional | 03/02/2017SE |
| K162962 | OrthAlign Plus SystemOLO · Traditional | 01/23/2017SE |
| K153237 | OrthAlign Plus SystemOLO · Traditional | 03/01/2016SE |
| K140331 | Orthalign Plus SystemOLO · Traditional | 06/10/2014SE |
Questions and answers
When was Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) cleared by the FDA?
Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) (K262253) received a 510(k) decision of Substantially Equivalent on July 31, 2026, 29 days after the submission was received.
What is the product code of K262253?
The FDA product code is ONN – Intraoperative Orthopedic Joint Assessment Aid, a Class II (moderate risk) device regulated under 21 CFR 882.4560.