510(k) · Cleared
ClearedAesculap OrthoPilot Next Generation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, LLC · OLO Orthopedic Stereotaxic Instrument
Cleared on May 16, 2016 as substantially equivalent to K090375 (Aesculap Implant System, Inc., 2009) after a 174-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- May 16, 2016
- Review
- 174 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003347 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK003347 OrthopilotKinamed, Inc. · 2001
- 3 generations backK013569 Orthopilot 2Aesculap, Inc. · 2002
- 2 generations backK080547 Orthopilot Next Generation, Model FS101-FS106Aesculap Implant System, Inc. · 2008
- 1 generation backK090375 Orthopilot Next Generation-Uka Software, Model FS210Aesculap Implant System, Inc. · 2009
- This deviceK153396 Aesculap OrthoPilot Next GenerationAesculap Implant Systems, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003347 | Orthopilot | Kinamed, Inc. | 2001 | — |
| −3 | K013569 | Orthopilot 2 | Aesculap, Inc. | 2002 | — |
| −2 | K080547 | Orthopilot Next Generation, Model FS101-FS106 | Aesculap Implant System, Inc. | 2008 | — |
| −1 | K090375 | Orthopilot Next Generation-Uka Software, Model FS210 | Aesculap Implant System, Inc. | 2009 | — |
| 0 (this device) | K153396 | Aesculap OrthoPilot Next Generation | Aesculap Implant Systems, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K090375 | Orthopilot Next Generation-Uka Software, Model FS210Summary page 4…KA, TKR, and UKA software modules are substantially equivalent to the currently marketed OrthoPilot® Next Generation UKA software module cleared in the primary predicate K090375; OrthoPilot® Next Generation TKA & TKR software modules cleared in reference predicate K080547 and the CAP markers/Polaris Spectr… | 2009 |
| † | K080547 | Orthopilot Next Generation, Model FS101-FS106 | 2008 |
| † | K141694 | Aesculap Orthopilot Next Generation | 2015 |
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 15 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K090375.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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/K153396 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153396: Aesculap OrthoPilot Next Generation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153396
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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