510(k) · Cleared
ClearedKneeAlign 2 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 Mar 2, 2017 as substantially equivalent to K103829 (Orthalign, Inc., 2011) and 1 other predicate after a 91-day review. Its family tree reaches back 12 generations to 1999. 1 later device descends from it.
- Decided
- Mar 2, 2017
- Review
- 91 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K983831 (1999). 40 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 8 generations between
- 3 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 2 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 1 generation backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- This deviceK163379 KneeAlign 2 SystemOrthalign, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK192653 PerseusOrthokey Italia S.R.L. · 2020
Show all 12 generations
- Root · 12 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 11 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 10 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 9 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 8 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 7 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 6 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 5 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 4 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 3 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 2 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 1 generation backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- This deviceK163379 KneeAlign 2 SystemOrthalign, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K192653PerseusOrthokey Italia S.R.L. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −11 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −10 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −9 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −8 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −7 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −6 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −5 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −4 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −3 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −2 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −1 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| 0 (this device) | K163379 | KneeAlign 2 System | Orthalign, Inc. | 2017 | — |
| +1 | K192653 | Perseus | Orthokey Italia S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 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 |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K103829 | Kneealign SystemSummary page 4…PRODUCT CODES OLO: Orthopedic Stereotaxic Instrument PREDICATE OrthAlign Plus® System (K153237) DEVICES KneeAlign® 2 System (K103829) SUBMISSION TYPE Traditional 510(k). The subject device is a modification to the previously cl… | 2011 |
| * | K153237 | OrthAlign Plus SystemSummary page 4…Class II, 21 CFR §882.4560 CLASSIFICATION PRODUCT CODES OLO: Orthopedic Stereotaxic Instrument PREDICATE OrthAlign Plus® System (K153237) DEVICES KneeAlign® 2 System (K103829) SUBMISSION TYPE Traditional 510(k). The subject device is a mod… | 2016 |
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 |
|---|---|---|---|
| K192653 | Perseus | 2020 | 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 18 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 40 ancestors have a recall of any class.
- Of its descendants, K192653 (Orthokey Italia S.R.L., 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103829.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 KneeAlign® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign system facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes.
Orthopedic surgical procedures include but are not limited to:
* Total Knee Arthroplasty
* Unicompartmental Knee Arthroplasty — Tibial Transverse Resection
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/K163379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163379: KneeAlign 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163379
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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