Pure Global
Singapore HSA registration DE0510692

DePuy VELYS™ Robotic-Assisted Solution for Unicompartmental Knee

Singapore flagSingapore·CLASS B·DePuy Ireland UC·Registered May 07, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0510692
Registration Date
May 07, 2025
Retention Due Date
May 06, 2026
Product description
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.
Product Owner
Name
DePuy Ireland UC
Short Name
DePuy Ireland UC
Address
Loughbeg, Ringaskiddy, Co. Cork, Ireland, IRELAND
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
VELYS™ Array Drill Pin 100 mm x 4 mm VELYS™ Array Drill Pin 125 mm x 4 mm VELYS™ Array Drill Pin 175 mm x 4 mm VELYS™ Puresight™ Array Set - Knee VELYS™ Oscillating Saw Blade - 13mm VELYS™ Base Station VELYS™ Satellite Station VELYS™ Saw Handpiece VELYS™ Array Clamp VELYS™ Device Array Interface
Model Identifier(s)
451570004 451570005 451570006 451570011 451570013 451570100 451570101 451570102 451570107 451570109
About this record

Access comprehensive regulatory information for DePuy VELYS™ Robotic-Assisted Solution for Unicompartmental Knee in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510692 and owned by DePuy Ireland UC. The device was registered on May 07, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B