News and analysis on medical technology
FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears OrthAlign's Lantern ASC Handheld Knee Navigation System

The 510(k) adds a reusable navigation unit and ligament balancing to OrthAlign's palm-sized system, which the company is pitching to ambulatory surgery centers as an alternative to robots.

By News DeskJune 3, 20262 min read
Illustration of a knee joint with a total knee replacement implant
A medical illustration of a total knee replacement implant. Not the Lantern ASC system described in this article. Laboratoires Servier, CC BY-SA 3.0, via Wikimedia Commons · CC BY-SA 3.0
FDA cleared510(k) · K253507FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared OrthAlign's Lantern ASC system under 510(k) K253507 on June 2, 2026; the company announced it on June 3.
  • The system uses a palm-sized computer module and reference sensor to help surgeons determine alignment axes in knee replacement, and provides ligament balancing in primary or revision total knee arthroplasty.
  • OrthAlign's 510(k) summary lists bench, software, usability and cybersecurity testing, and states that clinical testing was not applicable.

The US Food and Drug Administration has cleared OrthAlign's Lantern ASC system, a handheld navigation system for knee replacement surgery, the Irvine, California, company said in a June 3 release distributed by PR Newswire and posted on its website.

The FDA's 510(k) database lists the clearance as K253507, a traditional 510(k) received on November 3, 2025, with a substantially equivalent decision on June 2, 2026. The device, listed as a packaged assembly of a reusable navigation unit and a Lantern ASC Smart Pack kit for the knee, falls under product code ONN, an intraoperative orthopedic joint assessment aid.

What the clearance covers

According to the clearance letter and 510(k) summary, Lantern ASC 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 surgery, and to help position implants relative to those axes. It also provides ligament balancing in primary or revision total knee arthroplasty. Example procedures listed are total knee arthroplasty, the tibial cut in unicompartmental (partial) knee arthroplasty, and ligament balancing.

The summary describes a palm-sized computer module and reference sensor that guide the surgeon through registering anatomical landmarks, calculating mechanical axes and positioning instruments. OrthAlign cited its earlier Lantern Surgical Assistant Knee, previously branded as the Harvey Surgical Assistant, as the primary predicate, and its Lantern Hip as a reference device for ligament balancing. Unlike the single-use predicate, the new system uses a non-sterile reusable navigation unit placed inside a sterile cover with a transfer tool, a design the summary compares with a Gyder Surgical hip system.

Testing listed in the summary includes software verification and validation, hardware testing, bench testing of angle measurement accuracy, usability testing, cybersecurity testing, and cleaning, sterilization and shipping validations. "Clinical testing is not Applicable," the summary states.

The ambulatory surgery center pitch

OrthAlign is aiming Lantern ASC at ambulatory surgery centers, which it calls the fastest-growing segment in orthopedics. The company said the system pairs a reusable navigation unit with a procedural Smart Pack Kit, works with existing Lantern instrumentation and is compatible with most implant systems.

The release contrasts the product with surgical robots, which it said "require massive upfront investment, lengthy setup times, and steep learning curves in the operation room." Chief executive Eric Timko said the company engineered Lantern ASC "to be a technology that leaves no stakeholder behind."

OrthAlign said Lantern ASC builds on more than 450,000 OrthAlign procedures, a company-reported figure. The release did not give pricing or a launch date. While the release mentions hip replacement in passing, the FDA clearance documents list knee procedures and ligament balancing.

Sources

  1. OrthAlign, Inc. Receives FDA 510(k) clearance for the Lantern ASC system (PR Newswire release, company website), OrthAlign, June 3, 2026
  2. 510(k) K253507: Lantern ASC, Smart Pack kit, Knee (database record), US Food and Drug Administration, June 2, 2026
  3. K253507 clearance letter and 510(k) summary, US Food and Drug Administration, June 2, 2026