510(k) · Cleared
ClearedOrthopilot Next Generation-Uka Software, Model FS210
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant System, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 23, 2009 as substantially equivalent to K080547 (Aesculap Implant System, Inc., 2008) after a 126-day review. Its family tree reaches back 3 generations to 2001. 21 later devices descend from it.
- Decided
- Jun 23, 2009
- Review
- 126 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003347 (2001). 6 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK003347 OrthopilotKinamed, Inc. · 2001
- 2 generations backK013569 Orthopilot 2Aesculap, Inc. · 2002
- 1 generation backK080547 Orthopilot Next Generation, Model FS101-FS106Aesculap Implant System, Inc. · 2008
- This deviceK090375 Orthopilot Next Generation-Uka Software, Model FS210Aesculap Implant System, Inc. · 2009
- Descendant · cites it directly · 19 of its ownK141694 Aesculap Orthopilot Next GenerationAesculap Implant Systems, LLC · 2015
- Descendant · 2 generations on · 18 of its ownK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- Descendant · 3 generations on · 15 of its ownK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- Descendant · 4 generations on · 12 of its ownK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- Descendant · 5 generations on · 8 of its ownK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K141694Aesculap Orthopilot Next GenerationAesculap Implant Systems, LLC · 2015 · cites it directly19descendants
- K153237OrthAlign Plus SystemOrthalign, Inc. · 2016 · 2 generations on18descendants
- K162962OrthAlign Plus SystemOrthalign, Inc. · 2017 · 3 generations on15descendants
- K171780OrthAlign Plus SystemOrthalign, Inc. · 2017 · 4 generations on12descendants
- K172462OrthAlign Plus SystemOrthalign, Inc. · 2017 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003347 | Orthopilot | Kinamed, Inc. | 2001 | — |
| −2 | K013569 | Orthopilot 2 | Aesculap, Inc. | 2002 | — |
| −1 | K080547 | Orthopilot Next Generation, Model FS101-FS106 | Aesculap Implant System, Inc. | 2008 | — |
| 0 (this device) | K090375 | Orthopilot Next Generation-Uka Software, Model FS210 | Aesculap Implant System, Inc. | 2009 | — |
| +1 | K141694 | Aesculap Orthopilot Next Generation | Aesculap Implant Systems, LLC | 2015 | — |
| +2 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| +3 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| +4 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| +5 | K172462 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K080547 | Orthopilot Next Generation, Model FS101-FS106Summary page 2…A) software module is substantially equivalent to our currently marketed OrthoPilot Total Knee Arthroscopy (TKA) software module cleared in Aesculap's 510(k) submission #K080547. %Q DEPARTMENT OF HEALTH &… | 2008 |
What descends from it? (21)
See all 212 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 8 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K141694 (Aesculap Implant Systems, LLC, 2015) has gone furthest, with 19 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. 2009, 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 OrthoPilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurements of bone alignment. It indicates angles and positions for implant placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090375: Orthopilot Next Generation-Uka Software, Model FS210.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090375
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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