510(k) · Cleared
ClearedLantern® Hip
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 Oct 3, 2024 as substantially equivalent to K171780 (Orthalign, Inc., 2017) after a 30-day review. Its family tree reaches back 14 generations to 1999. 1 later device descends from it.
- Decided
- Oct 3, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K983831 (1999). 45 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 10 generations between
- 3 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 2 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK242616 Lantern® HipOrthalign, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK262253 Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit…Orthalign, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 13 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 12 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 11 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 10 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 9 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 8 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 7 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 6 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 5 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 4 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 3 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 2 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK242616 Lantern® HipOrthalign, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −13 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −12 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −11 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −10 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −9 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −8 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −7 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −6 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −5 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −4 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −3 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| −2 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −1 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| 0 (this device) | K242616 | Lantern® Hip | Orthalign, Inc. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 K262253 Lantern Knee Navigation Unit…score 16.0 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K171780 | OrthAlign Plus SystemSummary page 5…ive Orthopedic Joint Assessment Aid DEVICE TRADE NAME Lantern® Hip PRIMARY PREDICATE DEVICE OrthAlign Plus System (K171780) Reference Device Harvey® Surgical Assistant (K200892) SUBMISSION TYPE… | 2017 |
| † | K200892 | Harvey (R) Surgical Assistant | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | 2026 | 0 |
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 25 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 45 ancestors have a recall of any class.
- Of its descendants, K262253 (Orthalign, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K171780.
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. 2024, 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® 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.
The Lantern® Hip is indicated for Total Hip Arthroplasty with an anterior hip approach (Direct Anterior Approach) and the patient in the supine position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242616: Lantern® Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242616
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026