HSA · registration DE0508780ONE Planner™ Hip
- Registration number
- DE0508780
- Model name
- ONE Planner™ Hip
- Model identifier
- CG200
- Registration date
- December 21, 2023
- Risk class
- Class B
- Product owner
- Zimmer CAS
- Registrant / registration holder
- ZIMMER PTE. LTD.
ONE Planner™ Hip (OPH) is an interactive software application intended to be used as a preoperative tool for Total Hip Arthroplasty. It enables 2D sizing and positioning of implants in the patient’s anatomy, calculates biomechanical measurements and performs functional analysis based on the patient’s pelvic kinematics. The biomechanical measurements include measurements related to leg length and femoral offset. The functional analysis includes determination of pelvic parameters (e.g. pelvic tilt), and cup orientation calculations. The software application consists of an automated templating system and a web-based templating user interface.
- Product owner address
- 75 Queen Street, Suite 3300, Montreal, Quebec, H3C 2N6, Canada
- Registrant address
- 401 COMMONWEALTH DRIVE, #06-03, HAW PAR TECHNO CENTRE, Singapore 149598
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.