510(k) · Cleared
ClearedOrthAlign Plus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthalign, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Apr 10, 2020 as substantially equivalent to K171780 (Orthalign, Inc., 2017) after a 30-day review. Its family tree reaches back 14 generations to 1999.
- Decided
- Apr 10, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K983831 (1999). 45 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 backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK200642 OrthAlign Plus SystemOrthalign, Inc. · 2020
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 deviceK200642 OrthAlign Plus SystemOrthalign, Inc. · 2020
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) | K200642 | OrthAlign Plus System | Orthalign, Inc. | 2020 | — |
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 |
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 OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 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 4…OLO: Orthopedic Stereotaxic Instrument PRIMARY PREDICATE DEVICE OrthAlign Plus® System (K171780) Reference Device(s) K163627 Shotel Ankle Arthrodesis Nail System… | 2017 |
| † | K163627 | Shotel Ankle Arthrodesis Nail System | 2017 |
| † | K162674 | BioPro Foot Plating Systems | 2017 |
| † | K132510 | Biopro - Infinity Plate Anchor System | 2013 |
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 21 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.
- 2 other devices also cite its predicate K171780.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The OrthAlign Plus® 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 OrthAlign Plus® system facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length discrepancy in Total Hip Arthroplasty.
Example orthopedic surgical procedures include but are not limited to:
• Total Knee Arthroplasty
• Total Hip Arthroplasty: Anterior/Posterior
• Unicompartmental Knee Arthroplasty: Tibial transverse resection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200642: OrthAlign Plus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200642
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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