510(k) · Cleared
ClearedOrthopilot Next Generation, Model FS101-FS106
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant System, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on May 23, 2008 as substantially equivalent to K013569 (Aesculap, Inc., 2002) after an 85-day review. Its family tree reaches back 2 generations to 2001. 22 later devices descend from it.
- Decided
- May 23, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003347 (2001). 5 ancestors in all. 22 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003347 OrthopilotKinamed, Inc. · 2001
- 1 generation backK013569 Orthopilot 2Aesculap, Inc. · 2002
- This deviceK080547 Orthopilot Next Generation, Model FS101-FS106Aesculap Implant System, Inc. · 2008
- Descendant · cites it directly · 21 of its ownK090375 Orthopilot Next Generation-Uka Software, Model FS210Aesculap Implant System, Inc. · 2009
- Descendant · 2 generations on · 19 of its ownK141694 Aesculap Orthopilot Next GenerationAesculap Implant Systems, LLC · 2015
- 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 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K090375Orthopilot Next Generation-Uka Software, Model FS210Aesculap Implant System, Inc. · 2009 · cites it directly21descendants
- K141694Aesculap Orthopilot Next GenerationAesculap Implant Systems, LLC · 2015 · 2 generations on19descendants
- 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 |
|---|---|---|---|---|---|
| −2 | K003347 | Orthopilot | Kinamed, Inc. | 2001 | — |
| −1 | K013569 | Orthopilot 2 | Aesculap, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | K141694 | Aesculap Orthopilot Next Generation | Aesculap Implant Systems, LLC | 2015 | — |
| +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 |
|---|---|---|
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K013569 | Orthopilot 2 | 2002 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090375 | Orthopilot Next Generation-Uka Software, Model FS210 | 2009 | 21 |
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 7 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090375 (Aesculap Implant System, Inc., 2009) has gone furthest, with 21 descendants of its own.
- 4 other devices also cite its predicate K013569.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 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 optimally position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080547: Orthopilot Next Generation, Model FS101-FS106.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080547
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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