510(k) · Cleared
ClearedPigalileo TKR Base V2.3 and Cas V4.1
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 Mar 11, 2009 as substantially equivalent to K082267 (Smith & Nephew, Inc., 2008) after a 30-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 11, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002053 (2000). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 4 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 3 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 2 generations backK061362 Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
- 1 generation backK082267 Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1Smith & Nephew, Inc. · 2008
- This deviceK090313 Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −4 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −3 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −2 | K061362 | Pigalileo Total Knee Replacement (TKR) System | Plus Orthopedics AG | 2006 | — |
| −1 | K082267 | Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1 | Smith & Nephew, Inc. | 2008 | — |
| 0 (this device) | K090313 | Pigalileo TKR Base V2.3 and Cas V4.1 | Smith & Nephew, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 4 | 0 |
| 2002 | 2 | 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 |
|---|---|---|---|
| * | K082267 | Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1Summary page 1…Dscriptiown 51((~ C6ri'66,13e Smith & Nephew, Inc. PiGatileo TKR Base V2.1 /CA V40K082267 10/29/08 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
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 Total Knee Replacement (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 used 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 surgical procedures include but are not limited to:
* Total knee replacement supporting bone referencing technique
* Total knee replacement supporting ligament balancing technique
* Minimally invasive total knee replacement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090313 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090313: Pigalileo TKR Base V2.3 and Cas V4.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090313
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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