# K233227: VELYS™ Robotic-Assisted Solution

- Pathway: 510(k) (Special)
- Applicant: Depuy Ireland UC
- Decided: Dec 14, 2023 after 77 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K002053 (2000). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202769: VELYS™ Robotic-Assisted Solution, Depuy Ireland UC (2021) Summary page 5.

## Most influential descendants
- K260480: VELYS™ Robotic-Assisted Solution (2026), 0 descendants of its own

## Indications for use
The VELYS ™ Robotic-Assisted Solution is intended for stereotaxic surgery to help the surgeon to identify the relative position and orientation of anatomical structures, plan the position of the femoral and tibial implant components intraoperatively and prepare 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/K233227
Methodology: https://510kreport.com/methodology