510(k) · Cleared
ClearedSmith & Nephew Pigalileo Screw Targeting System, Version 1.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Sep 11, 2009 as substantially equivalent to K090420 (Smith & Nephew, Inc., 2009) after a 28-day review. Its family tree reaches back 8 generations to 2001. 77 later devices descend from it.
- Decided
- Sep 11, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010612 (2001). 27 ancestors in all, the oldest K983831 (1999). 77 later devices descend from it, 7 citing it directly.
- Root · 8 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 7 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 6 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 5 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 4 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 3 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 2 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 1 generation backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- This deviceK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- Descendant · cites it directly · 75 of its ownK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- Descendant · cites it directly · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
- Descendant · 3 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · 3 generations on · 12 of its ownK163650 ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · cites it directly75descendants
- K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · cites it directly69descendants
- K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · 2 generations on53descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 3 generations on31descendants
- K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −7 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −6 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −5 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −4 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −3 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −2 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −1 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| +1 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| +1 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| +2 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
| +3 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +3 | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | Wrightmedicaltechnologyinc | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0Summary page 1…Nee, ~ 5Inc9(is). PGaioreTargettem ISmith & Nephew, Inc. PiGalileo Screw Targeting System V1.0 K090420 10/29/08 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2009 |
What descends from it? (77)
See all 777 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | 2010 | 75 |
| K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws… | 2011 | 69 |
| K102967 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2 | 2010 | 3 |
| K110240 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1 | 2011 | 2 |
| K130748 | Smith & Nephew Sureshot Distal Targeting System V3.0 | 2013 | 1 |
| K180277 | Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter | 2018 | 0 |
| K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0 | 2017 | 0 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K100107 (Smith & Nephew, Inc., 2010) has gone furthest, with 75 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The Smith & Nephew PiGalileo Screw Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew PiGalileo Screw Targeting System V1.1 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092497: Smith & Nephew Pigalileo Screw Targeting System, Version 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092497
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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