510(k) · Cleared
ClearedVELYS™ Robotic-Assisted Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 25, 2026 as substantially equivalent to K233227 (Depuy Ireland UC, 2023) after a 132-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Jun 25, 2026
- Review
- 132 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K002053 (2000). 28 ancestors in all, the oldest K983831 (1999). No later device cites it as a predicate yet.
- Root · 10 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 6 generations between
- 3 generations backK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- 2 generations backK202769 VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2021 · Recalled
- 1 generation backK233227 VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2023
- This deviceK260480 VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2026
Show all 10 generations
- Root · 10 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 9 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 8 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 7 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 6 generations backK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- 5 generations backK063408 Ctlogics Navigations SystemsPraxim Medivision, SA · 2007
- 4 generations backK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
- 3 generations backK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- 2 generations backK202769 VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2021 · Recalled
- 1 generation backK233227 VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2023
- This deviceK260480 VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −9 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −8 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −7 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −6 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −5 | K063408 | Ctlogics Navigations Systems | Praxim Medivision, SA | 2007 | — |
| −4 | K081232 | Total Knee Surgetics Navigation System with Praxiteles | Praxim | 2008 | — |
| −3 | K090953 | Total Knee Surgetics Navigation System with Iblock | Praxim Medivision, SA | 2010 | 2 |
| −2 | K202769 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2021 | 1 |
| −1 | K233227 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2023 | — |
| 0 (this device) | K260480 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K233227 | VELYS™ Robotic-Assisted SolutionSummary page 5…882.4560 Product Code(s) OLO | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233227 VELYS™ Robotic-Assisted Solution OLO Device Description Summary 21 CFR 807.92(a)(4) The VELYS™ Robotic-Assisted Solution is an i… | 2023 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 28 ancestors have 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. 2026, 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 VELYS™ Robotic-Assisted Solution is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anatomical structures, planning the position of the femoral and tibial implant components intraoperatively, and preparing the bones during total knee arthroplasty.
When indicated for total knee arthroplasty, the VELYS™ Robotic-Assisted Solution is indicated for use with the ATTUNE™ Total Knee System and its cleared indications for use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260480: VELYS™ Robotic-Assisted Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260480
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026