510(k) · Cleared
ClearedPigalileo Total Hip Replacement (THR) Software Application V3.0
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 Feb 20, 2009 as substantially equivalent to K070731 (Plus Orthopedics AG, 2007) after a 79-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Feb 20, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010612 (2001). 21 ancestors in all, the oldest K983831 (1999). No later device cites it as a predicate yet.
- 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 deviceK083565 Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc. · 2009
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) | K083565 | Pigalileo Total Hip Replacement (THR) Software Application V3.0 | Smith & Nephew, Inc. | 2009 | — |
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 |
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 |
|---|---|---|---|
| * | K070731 | Pigalileo Total Hip Replacement (THR) SystemSummary page 1…AGPiGalileo Total Hip Replacement PLUSOrthpedics PLUSOthopedcs AG(THR) System (THR V2.5 Software) K070731 7/31/07 o;ERVICES ('" ~ DEPARTMENT OF HEALTH 8< HUMAN SERVICES… | 2007 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K070731.
How does its category compare?
All HAW devicesHAW Neurological 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 · 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 PiGalileo Total Hip Replacement (THR) V3.0 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. hip,.center, pelvic plane etc.).
Examples of surgical procedures includebut 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/K083565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083565: Pigalileo Total Hip Replacement (THR) Software Application V3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083565
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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