Manufacturer
Depuy Ireland UCVELYS™ Robotic-Assisted Solution
Country / Region:Ireland (IE)Submission type:Special
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K233227
- Device name
- VELYS™ Robotic-Assisted Solution
- Company
- Depuy Ireland UC
- 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
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