510(k) · Cleared
ClearedPigalileo 4TH Generation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jul 18, 2008 as substantially equivalent to K061362 (Plus Orthopedics AG, 2006) and 1 other predicate after a 109-day review. Its family tree reaches back 6 generations to 2001. 79 later devices descend from it.
- Decided
- Jul 18, 2008
- Review
- 109 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K010612 (2001). 21 ancestors in all, the oldest K983831 (1999). 79 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 5 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 4 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 3 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 2 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 1 generation backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- This deviceK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 78 of its ownK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 77 of its ownK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 75 of its ownK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- Descendant · 4 generations on · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009 · cites it directly78descendants
- K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009 · 2 generations on77descendants
- K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · 3 generations on75descendants
- K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 3 generations on69descendants
- K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · 4 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −5 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −4 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −3 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −2 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −1 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| 0 (this device) | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| +1 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| +2 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| +3 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| +3 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| +4 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 9 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 2 | 0 |
| 2023 | 10 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K061362 | Pigalileo Total Knee Replacement (TKR) SystemSummary page 1…ew PiGalileo 4 th Generation System is substantially equivalent to previously cleared devices listed below. PLUS Orthopedics AG PiGalileo Total Knee K061362 10/06/06 Replacement (TKR) System PiGalileo Total Hip PLUS Ort… | 2006 |
| * | K070731 | Pigalileo Total Hip Replacement (THR) SystemSummary page 1…10/06/06 Replacement (TKR) System PiGalileo Total Hip PLUS OrthopedicsAG Replacem1ent-IT-HR-) S-ystem -K070731 ._7/31/07 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heal… | 2007 |
What descends from it? (79)
See all 791 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | 2009 | 78 |
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 1.2 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K090420 (Smith & Nephew, Inc., 2009) has gone furthest, with 78 descendants of its own.
- 5 other devices also cite its predicate K061362.
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 PiGalileo 4th Generation System is intended for use as a stereotaxic instrument to assist in the positioning of total knee and total hip replacement components intra-operatively. The system is a computer controlled image guided system equipped with a three-dimensional tracking sub-system. The PiGalileo System is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks; as such instruments are precisely positioned relative to these axes by displaying their locations. This allows for accurate positioning of instruments used for total knee and total hip replacement surgery and provides intraoperative measurements of bone alignment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080875 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080875: Pigalileo 4TH Generation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080875
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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