Company · US
Orthalign, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2026. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (2 in 12 months)
2recalls (2 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) Orthalign, Inc. | ONN |
| Jun 2, 2026 | K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee Orthalign, Inc. | ONN |
| Oct 3, 2024 | K242616 | Lantern® Hip Orthalign, Inc. | ONN |
| Jun 18, 2020 | K200892 | Harvey(R) Surgical Assistant Orthalign, Inc. | OLO |
| Apr 10, 2020 | K200642 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Nov 22, 2017 | K172462 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Jul 11, 2017 | K171780 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Mar 2, 2017 | K163379 | KneeAlign 2 System Orthalign, Inc. | OLO |
| Jan 23, 2017 | K162962 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Mar 1, 2016 | K153237 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Jun 10, 2014 | K140331 | ORTHALIGN PLUS SYSTEM Orthalign, Inc. | OLO |
| Nov 8, 2013 | K130387 | ORTHOALIGN PLUS SYSTEM Orthalign, Inc. | OLO |
| Apr 4, 2011 | K103829 | KNEEALIGN SYSTEM Orthalign, Inc. | OLO |
| Mar 22, 2010 | K093998 | KNEEALIGN SYSTEM WITH REFERENCE SENSOR Orthalign, Inc. | OLO |
| Sep 25, 2009 | K091411 | KNEEALIGN SYSTEM Orthalign, Inc. | OLO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Orthalign, Inc Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7
REF:402567
component Lantern Knee System Open, Classified |
OLO | K200892 |
| Mar 24, 2026 | Orthalign, Inc Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5
REF:402566
component Lantern Knee System Open, Classified |
OLO | K200892 |