# K240211: VELYS Robotic-Assisted Solution

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Jun 5, 2024 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K172301: Mako Partial Knee Application, Mako Surgical Corp. (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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 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.

Source page: https://510kreport.com/device/K240211
Methodology: https://510kreport.com/methodology