510(k) · Cleared
ClearedLantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthalign, Inc. · ONN Intraoperative Orthopedic Joint Assessment Aid
Cleared on Jul 31, 2026 as substantially equivalent to K200892 (Orthalign, Inc., 2020) and 2 other predicates after a 29-day review. Its family tree reaches back 15 generations to 1999.
- Decided
- Jul 31, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K983831 (1999). 47 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 11 generations between
- 3 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK242616 Lantern® HipOrthalign, Inc. · 2024
- This deviceK262253 Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit…Orthalign, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 14 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 13 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 12 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 11 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 10 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 9 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 8 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 7 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 6 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 5 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 4 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 3 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK242616 Lantern® HipOrthalign, Inc. · 2024
- This deviceK262253 Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit…Orthalign, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −14 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −13 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −12 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −11 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −10 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −9 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −8 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −7 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −6 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −5 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −4 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| −3 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −2 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −1 | K242616 | Lantern® Hip | Orthalign, Inc. | 2024 | — |
| 0 (this device) | K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | Orthalign, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ONN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ONN device
- #1 K253507 Packaged Assembly, Reusable Navigation Unit…score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200892 | Harvey (R) Surgical AssistantSummary page 5…882.4560 Product Code(s) ONN I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200892 Lantern Surgical Assistant OLO K242616 Lantern Hip ONN K140331 OrthAlign Plus OLO | Device Description Summary 21 CFR 807.92(a)(… | 2020 |
| * | K242616 | Lantern® HipSummary page 5…y Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200892 Lantern Surgical Assistant OLO K242616 Lantern Hip ONN K140331 OrthAlign Plus OLO | Device Description Summary 21 CFR 807.92(a)(4) The Lantern system utilizes a palm… | 2024 |
| * | K140331 | Orthalign Plus SystemSummary page 5…ices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200892 Lantern Surgical Assistant OLO K242616 Lantern Hip ONN K140331 OrthAlign Plus OLO | Device Description Summary 21 CFR 807.92(a)(4) The Lantern system utilizes a palm sized computer module an… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 47 ancestors have a recall of any class.
- 1 other device also cites its predicate K200892.
How does its category compare?
All ONN devicesONN Intraoperative Orthopedic Joint Assessment Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · ONN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONN
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONN
5in 2025
MAUDE reports naming product code ONN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 6 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 3 | 100 | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Lantern Knee Indications for Use: The Lantern Knee 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 surgical procedures. The Lantern Knee facilitates the accurate positioning of implants relative to these alignment axes. Ligament balancing is provided by Lantern Knee in primary or revision Total Knee Arthroplasty.…
Read the full statement (186 words)
Lantern Knee Indications for Use:
The Lantern Knee 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 surgical procedures. The Lantern Knee facilitates the accurate positioning of implants relative to these alignment axes. Ligament balancing is provided by Lantern Knee in primary or revision Total Knee Arthroplasty.
Example orthopedic surgical procedures include but are not limited to:
• Total Knee Arthroplasty
• Unicompartmental Knee Arthroplasty: Tibial transverse resection
• Ligament Balancing
Lantern Hip Indications for use:
Lantern Hip 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 surgical procedures. Lantern Hip facilitates the accurate positioning of implants relative to these alignment axes.
The system aids the surgeon in controlling leg length and offset discrepancies. Lantern Hip is indicated for Total Hip Arthroplasty with the Direct Anterior Approach and the patient in the supine position, or through a posterior-based approach with the patient in the lateral position. Note, offset is only available with the Direct Anterior Approach.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262253: Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262253
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026