510(k) · Cleared
ClearedPigalileo Total Knee Replacement (TKR) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics AG · HAW Neurological Stereotaxic Instrument
Cleared on Oct 6, 2006 as substantially equivalent to K020298 (Plus Orthopedics, 2002) and 4 other predicates after a 143-day review. Its family tree reaches back 3 generations to 2000. 126 later devices descend from it.
- Decided
- Oct 6, 2006
- Review
- 143 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K002053 (2000). 9 ancestors in all. 126 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 2 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 1 generation backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- This deviceK061362 Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
- Descendant · cites it directly · 81 of its ownK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- Descendant · cites it directly · 79 of its ownK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- Descendant · 2 generations on · 78 of its ownK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 77 of its ownK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- Descendant · 4 generations on · 75 of its ownK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
Showing 5 of 126 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 126 · See all- K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007 · cites it directly81descendants
- K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008 · cites it directly79descendants
- K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009 · 2 generations on78descendants
- K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009 · 3 generations on77descendants
- K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · 4 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −2 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −1 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| 0 (this device) | K061362 | Pigalileo Total Knee Replacement (TKR) System | Plus Orthopedics AG | 2006 | — |
| +1 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| +1 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| +2 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| +3 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| +4 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K020298 | Galileo Cas/Nav TKR SystemSummary page 1…2.3 Classification Name: Stereotaxic instrument E.3 Substantial Equivalence Claimed to Predicate Devices 3.1 Galileo CAS/NAV TKR System, K020298, cleared May 2, 2002 3.2 OrthoPilotO 2 Navigation Platform, K003347, cleared February 23, 2001, an… | 2002 |
| * | K003347 | OrthopilotSummary page 1…quivalence Claimed to Predicate Devices 3.1 Galileo CAS/NAV TKR System, K020298, cleared May 2, 2002 3.2 OrthoPilotO 2 Navigation Platform, K003347, cleared February 23, 2001, and K01 3569, cleared April 4, 2002 3.3 NavitrackT System - Optical TKI… | 2001 |
| * | K013569 | Orthopilot 2Summary page 1…Galileo CAS/NAV TKR System, K020298, cleared May 2, 2002 3.2 OrthoPilotO 2 Navigation Platform, K003347, cleared February 23, 2001, and K01 3569, cleared April 4, 2002 3.3 NavitrackT System - Optical TKIR CT-Less, K021760, cleared August 27, 20… | 2002 |
| * | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120Summary page 1…Navigation Platform, K003347, cleared February 23, 2001, and K01 3569, cleared April 4, 2002 3.3 NavitrackT System - Optical TKIR CT-Less, K021760, cleared August 27, 2002, and K 043536, cleared January 14, 2005 E.4 Device Description Th… | 2002 |
| * | K043536 | Navitrack System - S&N Image Free KneeSummary page 1…1, and K01 3569, cleared April 4, 2002 3.3 NavitrackT System - Optical TKIR CT-Less, K021760, cleared August 27, 2002, and K 043536, cleared January 14, 2005 E.4 Device Description The PiGalileol Navigation (NAV) Total Knee Replacement… | 2005 |
What descends from it? (126)
See all 1266 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070731 | Pigalileo Total Hip Replacement (THR) System | 2007 | 81 |
| K080875 | Pigalileo 4TH Generation System | 2008 | 79 |
| K081232 | Total Knee Surgetics Navigation System with Praxiteles | 2008 | 18 |
| K083872 | Imns Medacta Navigation System | 2009 | 14 |
| K102990 | Brainlab Knee | 2011 | 7 |
| K082267 | Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1 | 2008 | 1 |
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 6 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K070731 (Plus Orthopedics AG, 2007) has gone furthest, with 81 descendants of its own.
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 PiGalileo TKR System is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g., ligament tension, limb alignment, etc.).
Examples of some surgical procedures include but are not limited to:
* Total knee replacement supporting both bone referencing and ligament balancing techniques
* Minimally invasive total knee replacement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061362: Pigalileo Total Knee Replacement (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/K061362
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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