510(k) · Cleared
ClearedOrthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Feb 6, 2008 as substantially equivalent to K050752 (Aesculap, Inc., 2005) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Feb 6, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003347 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK003347 OrthopilotKinamed, Inc. · 2001
- 2 generations backK013569 Orthopilot 2Aesculap, Inc. · 2002
- 1 generation backK050752 Aesculap Orthopilot 2 Tha V 2.0Aesculap, Inc. · 2005
- This deviceK072899 Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0Aesculap Implant Systems, Inc. · 2008
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 | K050752 | Aesculap Orthopilot 2 Tha V 2.0 | Aesculap, Inc. | 2005 | — |
| 0 (this device) | K072899 | Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0 | Aesculap Implant Systems, Inc. | 2008 | — |
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 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? (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 |
|---|---|---|---|
| * | K050752 | Aesculap Orthopilot 2 Tha V 2.0Summary page 2…eves that the Orthopilot 2 THA Software Module 3.0 is substantially equivalent to our currently marketed THA Module 2.0 that was cleared in Aesculap's 510(k) submission #K050752 and THA Module 1.0 in the original submission #KO1 3569 for Orthopilot 2.… | 2005 |
| * | K013569 | Orthopilot 2 | 2002 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K050752.
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® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system 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/K072899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072899: Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072899
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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