MyKnee
Medacta International SA · Model 9.2711M
MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#1+
Intended use: A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.
Key tips
- ·Never bypass a radiation interlock to "just get the image" - this is one of the few true zero-tolerance rules in BMET work.
- ·Trend image-quality phantom results over time - drift shows up before an outright failure does.
- ·Portable/mobile units take real physical abuse from transport - check wheel locks and cable strain reliefs more often than fixed units.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily QC per modality: image-quality phantom test
- ·Tube and detector inspection
- ·Annual state-required radiation safety survey
- ·Vendor-scheduled preventive maintenance
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Orthopaedic prosthesis implantation positioning instrument, single-use
- FDA product classification
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Radiology / Imaging department
- Emergency Department (portable units)
- Operating Room (C-arms)
- Cath lab
- Bedside ICU (portable X-ray)
Documents & Manuals
No documents available for this device yet.
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