510(k) · Cleared
ClearedPackaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
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 Jun 2, 2026 as substantially equivalent to K200892 (Orthalign, Inc., 2020) and 1 other predicate after a 211-day review. Its family tree reaches back 14 generations to 1999.
- Decided
- Jun 2, 2026
- Review
- 211 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K983831 (1999). 46 ancestors in all. No later device cites it as a predicate yet.
- 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 backK200892 Harvey (R) Surgical AssistantOrthalign, Inc. · 2020 · Recalled
- This deviceK253507 Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack…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 backK200892 Harvey (R) Surgical AssistantOrthalign, Inc. · 2020 · Recalled
- This deviceK253507 Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack…Orthalign, Inc. · 2026
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 | K200892 | Harvey (R) Surgical Assistant | Orthalign, Inc. | 2020 | 2 |
| 0 (this device) | K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | 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 |
| 2025 | 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? (2)
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…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code IK200892 Lantern Surgical Assistant Knee (previously branded as Harvey(R) Surgical As… | 2020 |
| * | K243387 | GYDER® Hip SystemSummary page 6…807.92(a)(6) The following technological characteristics are identical between the modified device, the OrthAlign predicate device and/or the Gyder Surgical Hip System (K243387): -Intended Use [Identical to OrthAlign predicate K200892 and Gyder Surgical K243387] -Indications for Use [Identical to OrthAlig… | 2025 |
| † | K242616 | Lantern® Hip | 2024 |
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 1.4 years on median.
- 7 of the 46 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?
The Lantern® ASC system 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® ASC system facilitates the accurate positioning of implants relative to these alignment axes. Ligament balancing is provided by the Lantern® ASC system 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
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/K253507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253507: Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253507
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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