# K202769: VELYS™ Robotic-Assisted Solution

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Jan 14, 2021 after 115 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K002053 (2000). 26 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090953: Total Knee Surgetics Navigation System with Iblock, Praxim Medivision, SA (2010) Summary page 4.

## Most influential descendants
- K233227: VELYS™ Robotic-Assisted Solution (2023), 1 descendant of its own
- K260480: VELYS™ Robotic-Assisted Solution (2026), 0 descendants of its own
- K240721: ExcelsiusFlex™ (2024), 0 descendants of its own

## Recalls of this device
- Mar 11, 2022 · Class II · Z-1029-2022: 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 del

## Indications for use
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.

Source page: https://510kreport.com/device/K202769
Methodology: https://510kreport.com/methodology