# K253507: Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee

- Pathway: 510(k) (Traditional)
- Applicant: Orthalign, Inc.
- Decided: Jun 2, 2026 after 211 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: 14 generations back to K983831 (1999). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 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.
- K243387: GYDER® Hip System, Gyder Surgical Pty, Ltd. (2025) Summary page 6.

## Indications for use
The Lantern® ASC system 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® ASC system facilitates the accurate positioning of implants relative to these alignment axes. Ligament balancing is provided by the Lantern® ASC system 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

Source page: https://510kreport.com/device/K253507
Methodology: https://510kreport.com/methodology