510(k) · Cleared
ClearedPigalileo Total Hip Replacement (THR) 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 Jul 31, 2007 as substantially equivalent to K060468 (Brainlab AG, 2006) and 3 other predicates after a 138-day review. Its family tree reaches back 5 generations to 2001. 81 later devices descend from it.
- Decided
- Jul 31, 2007
- Review
- 138 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K010612 (2001). 20 ancestors in all, the oldest K983831 (1999). 81 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 4 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 3 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 2 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 1 generation backK060468 Vectorvision HipBrainlab AG · 2006
- This deviceK070731 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
- Descendant · 4 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- 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
- K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 4 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −4 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −3 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −2 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −1 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| 0 (this device) | 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 |
| +4 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K060468 | Vectorvision HipSummary page 2…Federal Regulation (CFR), Part 882.4560 Stereotaxic instrument, Product Code: HAW 3. Substantial Equivalence Claimed to Predicate Device VectorVision Hip, K060468, manufactured by BrainLAB AG Orthopilot® 2 THA V 2.0, K050752, manufactured by Aesculap®, Inc. Stryker Navigation System, K… | 2006 |
| * | K050752 | Aesculap Orthopilot 2 Tha V 2.0Summary page 2…trument, Product Code: HAW 3. Substantial Equivalence Claimed to Predicate Device VectorVision Hip, K060468, manufactured by BrainLAB AG Orthopilot® 2 THA V 2.0, K050752, manufactured by Aesculap®, Inc. Stryker Navigation System, K022365, manufactured by Stryker Corporation PiGalileoTM Total… | 2005 |
| * | K022365 | Stryker Navigation System - Hip ModuleSummary page 2…cate Device VectorVision Hip, K060468, manufactured by BrainLAB AG Orthopilot® 2 THA V 2.0, K050752, manufactured by Aesculap®, Inc. Stryker Navigation System, K022365, manufactured by Stryker Corporation PiGalileoTM Total Knee Replacement (TKR) System, K061362, manufactured by Plus Orthope… | 2003 |
| * | K061362 | Pigalileo Total Knee Replacement (TKR) SystemSummary page 2…, K050752, manufactured by Aesculap®, Inc. Stryker Navigation System, K022365, manufactured by Stryker Corporation PiGalileoTM Total Knee Replacement (TKR) System, K061362, manufactured by Plus Orthopedics AG 4. Device Description The PiGalileoTM Total Hip Replacement (THR) sof… | 2006 |
What descends from it? (81)
See all 812 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1.2 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K080875 (Smith & Nephew, Inc., 2008) has gone furthest, with 79 descendants of its own.
- 2 other devices also cite its predicate K060468.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 PiGalileoTM Total Hip Replacement (THR) 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. hip center, pelvic plane etc.).
Examples of some surgical procedures include but are not limited to:
Primary total hip replacement
Revision hip surgery
Minimally invasive hip arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070731 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070731: Pigalileo Total Hip Replacement (THR) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070731
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