510(k) · Cleared

Cleared

VELYS Robotic-Assisted Solution

K240211510(k) TraditionalCleared Jun 5, 2024132-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy Ireland UC · OLO Orthopedic Stereotaxic Instrument

Cleared on Jun 5, 2024 after a 132-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided: Jun 5, 2024
Review: 132 days
Class: Class II
Product code: OLO
Recalls: None
Predicates: 1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K240211Source: FDA 510(k) database · How lineage is built

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

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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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K172301	FDA’s K172301 is Mako Partial Knee Application Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Mako Surgical Corp.	2017	6
†	K233227	VELYS™ Robotic-Assisted Solution	Depuy Ireland UC	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.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · OLO

40in 2025

2007high 45 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLO

119in 2025

2007high 176 (2015) · low 89 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OLO

1in 2025

2007high 7 (2023) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OLO

3,306in 2025

2007high 3,306 (2025) · low 0 (2007)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 unicompartmental knee arthroplasty.

When indicated for unicompartmental knee arthroplasty, the VELYS Robotic-Assisted Solution is indicated for use with the SIGMA HP Partial Knee Implants and INTUITION Instruments for SIGMA HP Partial Knee and their cleared indications for use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K240211 · printed Nov 5, 2026

Cite this page

510(k) Report. “K240211: VELYS Robotic-Assisted Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240211

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026