510(k) · Cleared
ClearedKneealign 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 4, 2011 as substantially equivalent to K093998 (Orthalign, Inc., 2010) and 1 other predicate after a 95-day review. Its family tree reaches back 8 generations to 1999. 39 later devices descend from it.
- Decided
- Apr 4, 2011
- Review
- 95 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K983831 (1999). 18 ancestors in all. 39 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 7 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 6 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 5 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 4 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 3 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 2 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 1 generation backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- This deviceK103829 Kneealign SystemOrthalign, Inc. · 2011
- Descendant · cites it directly · 31 of its ownK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- Descendant · 2 generations on · 29 of its ownK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- Descendant · 3 generations on · 18 of its ownK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- Descendant · 4 generations on · 15 of its ownK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- Descendant · 5 generations on · 12 of its ownK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K130387Orthoalign Plus SystemOrthalign, Inc. · 2013 · cites it directly31descendants
- K140331Orthalign Plus SystemOrthalign, Inc. · 2014 · 2 generations on29descendants
- K153237OrthAlign Plus SystemOrthalign, Inc. · 2016 · 3 generations on18descendants
- K162962OrthAlign Plus SystemOrthalign, Inc. · 2017 · 4 generations on15descendants
- K171780OrthAlign Plus SystemOrthalign, Inc. · 2017 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −7 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −6 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −5 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −4 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −3 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −2 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −1 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| 0 (this device) | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| +1 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| +2 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| +3 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| +4 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| +5 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K093998 | Kneealign System with Reference SensorSummary page 1…, 21 CFR §882.4560 CLASSIFICATION PRODUCT CODES OLO: Orthopedic Stereotaxic Instrument PREDICATE KneeAlign System with Reference Sensor (K093998) DEVICES Navitrack System- S&N Image Free Knee (K043 536) SUBSTANTIALLY EQUIVALENT To: The KneeAlign® 2 Syste… | 2010 |
| * | K043536 | Navitrack System - S&N Image Free KneeSummary page 1…opedic Stereotaxic Instrument PREDICATE KneeAlign System with Reference Sensor (K093998) DEVICES Navitrack System- S&N Image Free Knee (K043 536) SUBSTANTIALLY EQUIVALENT To: The KneeAlign® 2 System is substantially equivalent to the previously cleared KneeAlign System w… | 2005 |
What descends from it? (39)
See all 394 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K130387 (Orthalign, Inc., 2013) has gone furthest, with 31 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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® 2 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® 2 System facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to:
*Total Knee Arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103829 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103829: Kneealign System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103829
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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