510(k) · Cleared
Recalled · 2006Galileo Cas/Nav TKR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · HAW Neurological Stereotaxic Instrument
Cleared on May 20, 2002 as substantially equivalent to K003347 (Kinamed, Inc., 2001) after a 112-day review. Its family tree reaches back 1 generation to 2001. 127 later devices descend from it. It has been recalled once.
- Decided
- May 20, 2002
- Review
- 112 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003347 (2001). 127 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003347 OrthopilotKinamed, Inc. · 2001
- This deviceK020298 Galileo Cas/Nav TKR SystemPlus Orthopedics · 2002
- Descendant · cites it directly · 126 of its ownK061362 Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
- Descendant · 2 generations on · 81 of its ownK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- Descendant · 2 generations on · 79 of its ownK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- Descendant · 3 generations on · 78 of its ownK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- Descendant · 4 generations on · 77 of its ownK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 127 · See all- K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006 · cites it directly126descendants
- K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007 · 2 generations on81descendants
- K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008 · 2 generations on79descendants
- K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009 · 3 generations on78descendants
- K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009 · 4 generations on77descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003347 | Orthopilot | Kinamed, Inc. | 2001 | — |
| 0 (this device) | K020298 | Galileo Cas/Nav TKR System | Plus Orthopedics | 2002 | — |
| +1 | K061362 | Pigalileo Total Knee Replacement (TKR) System | Plus Orthopedics AG | 2006 | — |
| +2 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| +2 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| +3 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| +4 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 10 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 11 | 0 |
| 2021 | 11 | 0 |
| 2022 | 5 | 0 |
| 2023 | 16 | 0 |
| 2024 | 12 | 0 |
| 2025 | 12 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K003347 | OrthopilotSummary page 2…Equivalence: Indications: Performance data: \CodoRqd The GALILEO CAS/NAV TKR System is substantially equivalent to the OrthoPilot® (Aesculap, Inc. — K003347 — S/E 2/23/2001). Both systems are intended for the same medical indications and are technically similar. The GALILEO CAS/NAV T… | 2001 |
What descends from it? (127)
See all 1271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061362 | Pigalileo Total Knee Replacement (TKR) System | 2006 | 126 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2006 | Not classified | Z-0149-2007 | Other | Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 GALILEO CAS/NAV TKR System is intended for computer-assisted navigation of the GALILEO-CAS instruments with the aim to position the implants of the TC-PLUS™ Solution Knee (K000666 — S/E 10/13/00)
optimally for the patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020298: Galileo Cas/Nav TKR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020298
Report an extraction error
Are you the manufacturer?
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