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VELYS™ Robotic-Assisted Solution

Depuy Ireland UC

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

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Ireland (IE)

Product code

OLO
21 CFR 882.4560

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K233227
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
2023-09-28
Decision date
2023-12-14
Submission type
Special
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee SurgeryRobotic AssistanceNavigation System
Primary application
Knee Surgery
Classification source
AI classified

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.

Intended 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.

Device Description

The VELYS™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system for Total Knee Arthroplasty (TKA). 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. 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 05:50:52 UTC

Predicate devices

1

K233227 references 1 predicate/reference device

Cited as predicate

0

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