510(k) · Cleared
Recalled · Class II · 2022VELYS™ 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 Jan 14, 2021 as substantially equivalent to K090953 (Praxim Medivision, SA, 2010) after a 115-day review. Its family tree reaches back 8 generations to 2000. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 14, 2021
- Review
- 115 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K002053 (2000). 26 ancestors in all, the oldest K983831 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 7 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 6 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 5 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 4 generations backK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- 3 generations backK063408 Ctlogics Navigations SystemsPraxim Medivision, SA · 2007
- 2 generations backK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
- 1 generation backK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- This deviceK202769 VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2021
- Descendant · cites it directly · 1 of its ownK233227 VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2023
- Descendant · 2 generations on · 0 of its ownK260480 VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2026
- Descendant · cites it directly · 0 of its ownK240721 ExcelsiusFlex™Globus Medical, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −7 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −6 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −5 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −4 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −3 | K063408 | Ctlogics Navigations Systems | Praxim Medivision, SA | 2007 | — |
| −2 | K081232 | Total Knee Surgetics Navigation System with Praxiteles | Praxim | 2008 | — |
| −1 | K090953 | Total Knee Surgetics Navigation System with Iblock | Praxim Medivision, SA | 2010 | 2 |
| 0 (this device) | K202769 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2021 | — |
| +1 | K233227 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2023 | — |
| +2 | K260480 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2026 | — |
| +1 | K240721 | ExcelsiusFlex™ | Globus Medical, Inc. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K090953 | Total Knee Surgetics Navigation System with IblockSummary page 4…hopedics Regulation 882.4560 Product Code(s) OLO Legally marketed device(s) to TOTAL KNEE SURGETICS Navigation System with iBlock (K090953) which equivalence is claimed Reason for 510(k) submission New Device Device description The VELYS™ Robotic-Assis… | 2010 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2022 | Class II | Z-1029-2022 | Software design | System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K233227 (Depuy Ireland UC, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K090953.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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.
The VELYS™ Robotic-Assisted Solution is indicated for use with the ATTUNE Total Knee System and its cleared indications for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202769: 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/K202769
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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