Data / Medical devices / United States / OrthAlign, Inc.
OrthAlign, Inc.: FDA-registered device maker in Irvine, CA, United States, 15 510(k) clearances
OrthAlign, Inc. is registered with the FDA (registration 3007521480) in Irvine, CA, United States. It lists 5 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 31, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007521480
- Address
- 153 Technology, Irvine, CA, United States, 92618
- Owner or operator
- OrthAlign, Inc (10028839)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 11, 2009
- Registered through
- 2026
- Brand names listed
- HipAlign initial, Instrument, Lantern ASC Navigation Unit Knee, Lantern ASC Navigation Unit Knee & Hip, Lantern ASC Smart Pack Kit Hip, Lantern ASC Smart Pack Kit Knee, Lantern HIp Reference Sensor, Lantern Hip Femur Sensor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Cutting, Orthopedic | HTZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Intraoperative Orthopedic Joint Assessment Aid | ONN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | ONN | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| June 2, 2026 | K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | ONN | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| October 3, 2024 | K242616 | Lantern® Hip | ONN | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| June 18, 2020 | K200892 | Harvey(R) Surgical Assistant | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| April 10, 2020 | K200642 | OrthAlign Plus System | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| November 22, 2017 | K172462 | OrthAlign Plus System | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| July 11, 2017 | K171780 | OrthAlign Plus System | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| March 2, 2017 | K163379 | KneeAlign 2 System | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| January 23, 2017 | K162962 | OrthAlign Plus System | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| March 1, 2016 | K153237 | OrthAlign Plus System | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| June 10, 2014 | K140331 | ORTHALIGN PLUS SYSTEM | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| November 8, 2013 | K130387 | ORTHOALIGN PLUS SYSTEM | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| April 4, 2011 | K103829 | KNEEALIGN SYSTEM | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| March 22, 2010 | K093998 | KNEEALIGN SYSTEM WITH REFERENCE SENSOR | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
| September 25, 2009 | K091411 | KNEEALIGN SYSTEM | OLO | Substantially Equivalent | Orthalign, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 10, 2026 | 98516 | Class II | Ongoing | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Instrument, Cutting, Orthopedic
- All makers of Template
- All makers of Intraoperative Orthopedic Joint Assessment Aid
- All makers of Orthopedic Manual Surgical Instrument
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.