OrthAlign, Inc.
Irvine, CA, US
OrthAlign, Inc. appears in FDA device records in Irvine, CA. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for OrthAlign, Inc. between 2009 and 2026. The busiest year on record is 2017, with 4. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 4 |
| 2020 | 2 |
| 2024 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | ONN | Substantially Equivalent | |
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | ONN | Substantially Equivalent | |
| K242616 | Lantern® Hip | ONN | Substantially Equivalent | |
| K200892 | Harvey(R) Surgical Assistant | OLO | Substantially Equivalent | |
| K200642 | OrthAlign Plus System | OLO | Substantially Equivalent | |
| K172462 | OrthAlign Plus System | OLO | Substantially Equivalent | |
| K171780 | OrthAlign Plus System | OLO | Substantially Equivalent | |
| K163379 | KneeAlign 2 System | OLO | Substantially Equivalent | |
| K162962 | OrthAlign Plus System | OLO | Substantially Equivalent | |
| K153237 | OrthAlign Plus System | OLO | Substantially Equivalent | |
| K140331 | ORTHALIGN PLUS SYSTEM | OLO | Substantially Equivalent | |
| K130387 | ORTHOALIGN PLUS SYSTEM | OLO | Substantially Equivalent | |
| K103829 | KNEEALIGN SYSTEM | OLO | Substantially Equivalent | |
| K093998 | KNEEALIGN SYSTEM WITH REFERENCE SENSOR | OLO | Substantially Equivalent | |
| K091411 | KNEEALIGN SYSTEM | OLO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007521480 | 3007521480 | OrthAlign, Inc. | 153 Technology, Irvine, CA 92618 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1630-2026 | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Class II | Open, Classified | |
| Z-1629-2026 | 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) | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain