# K262253: Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)

- Pathway: 510(k) (Special)
- Applicant: Orthalign, Inc.
- Decided: Jul 31, 2026 after 29 days
- Product code: ONN (Intraoperative Orthopedic Joint Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K983831 (1999). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200892: Harvey (R) Surgical Assistant, Orthalign, Inc. (2020) Summary page 5.
- K242616: Lantern® Hip, Orthalign, Inc. (2024) Summary page 5.
- K140331: Orthalign Plus System, Orthalign, Inc. (2014) Summary page 5.

## Indications for use
Lantern Knee Indications for Use: The Lantern Knee is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The Lantern Knee facilitates the accurate positioning of implants relative to these alignment axes. Ligament balancing is provided by Lantern Knee in primary or revision Total Knee Arthroplasty. Example orthopedic surgical procedures include but are not limited to: • Total Knee Arthroplasty • Unicompartmental Knee Arthroplasty: Tibial transverse resection • Ligament Balancing Lantern Hip Indications for use: Lantern Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. Lantern Hip facilitates the accurate positioning of implants relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies. Lantern Hip is indicated for Total Hip Arthroplasty with the Direct Anterior Approach and the patient in the supine position, or through a posterior-based approach with the patient in the lateral position. Note, offset is only available with the Direct Anterior Approach.

Source page: https://510kreport.com/device/K262253
Methodology: https://510kreport.com/methodology