510(k) · Cleared
ClearedPigalileo Cas, Version 4.0 and TKR Base, Version 2.1
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 Oct 29, 2008 as substantially equivalent to K061362 (Plus Orthopedics AG, 2006) after a 79-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Oct 29, 2008
- Review
- 79 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002053 (2000). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 3 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 2 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 1 generation backK061362 Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
- This deviceK082267 Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1Smith & Nephew, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK090313 Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090313Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −3 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −2 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −1 | K061362 | Pigalileo Total Knee Replacement (TKR) System | Plus Orthopedics AG | 2006 | — |
| 0 (this device) | K082267 | Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1 | Smith & Nephew, Inc. | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (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 |
|---|---|---|---|
| * | K061362 | Pigalileo Total Knee Replacement (TKR) SystemSummary page 1…CRIPTIPN 510tK) CLEARANCE DAT PLUS Orthopedics AG PiGalileo Total Knee K Replacement (TKR) System K061362 10/06/06 J~~… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090313 | Pigalileo TKR Base V2.3 and Cas V4.1 | 2009 | 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 2.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K090313 (Smith & Nephew, Inc., 2009) has gone furthest, with 0 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 Smith & Nephew PiGatileo System TKR is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. Itprovides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intraoperatively (e.g. ligament tension, limb alignment, etc.)
Examples of some 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/K082267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082267: Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082267
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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