Orthalign, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Orthalign, Inc.” (first 2009, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 91 days. Since 2017 the median was 76 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 266 |
| 2014 | 1 | 120 |
| 2015 | 0 | — |
| 2016 | 1 | 113 |
| 2017 | 4 | 91 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 53 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 2 | 120 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthalign, Inc. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 12 | 12 |
| ONN | Intraoperative Orthopedic Joint Assessment Aid | 3 | 3 |
Review panels
- Orthopedic (15)
Most recent Orthalign, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | ONN | 2026-07-31 | 29 |
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | ONN | 2026-06-02 | 211 |
| K242616 | Lantern® Hip | ONN | 2024-10-03 | 30 |
| K200892 | Harvey(R) Surgical Assistant | OLO | 2020-06-18 | 76 |
| K200642 | OrthAlign Plus System | OLO | 2020-04-10 | 30 |
| K172462 | OrthAlign Plus System | OLO | 2017-11-22 | 100 |
| K171780 | OrthAlign Plus System | OLO | 2017-07-11 | 26 |
| K163379 | KneeAlign 2 System | OLO | 2017-03-02 | 91 |
| K162962 | OrthAlign Plus System | OLO | 2017-01-23 | 91 |
| K153237 | OrthAlign Plus System | OLO | 2016-03-01 | 113 |
5 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 2 initiated in the last five years. Most recent: 2026-02-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthalign, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Orthalign, Inc.” (first 2009, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Orthalign, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthalign, Inc. is 91 days. Since 2017: 76 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthalign, Inc.?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 12); ONN (Intraoperative Orthopedic Joint Assessment Aid, 3).
Next steps
- See all 15 Orthalign, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLO, Orthalign, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.