# K260480: VELYS™ Robotic-Assisted Solution

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Jun 25, 2026 after 132 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: 10 generations back to K002053 (2000). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233227: VELYS™ Robotic-Assisted Solution, Depuy Ireland UC (2023) Summary page 5.

## 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. When indicated for 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/K260480
Methodology: https://510kreport.com/methodology