VELYS Robotic-Assisted Solution— 510(k) K202769

Clearance details

Applicant

Depuy Ireland UC

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2020-09-21

Decision date

2021-01-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ringaskiddy, Co. Cork, IE

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• K253551 — VELYS Hip Navigation2026-03-06

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1029-2022 — VELYS Robotic-Assisted Solution Base Product No.: 451570100Class II·Terminated·DePuy Orthopaedics, Inc.·20220311

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202769.