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VELYS Robotic-Assisted Solution

Depuy Ireland UC

Country / Region:Ireland (IE)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Ireland (IE)

Product code

OLO
21 CFR 882.4560

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Device details

FDA 510(k) registration fields

K number
K240211
Device name
VELYS Robotic-Assisted Solution
Country / Region
Ireland(IE)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2024-01-25
Decision date
2024-06-05
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee SurgeryNavigation System
Primary application
Knee Surgery
Classification source
AI classified

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.

Intended 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.

Device Description

The VELYS™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system. It is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anatomical structures and landmarks, planning the position of the femoral and tibial implant components intraoperatively, and preparing the bones during total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA). The image-free system uses a dedicated optical tracking device to acquire anatomical landmarks intra-operatively. These landmarks are then used to plan the femoral and tibial implant locations based on the surgeon's preferred surgical technique and placement.

Summary parsed at:2026-06-19 05:30:30 UTC

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