Vendor/Manufacturer: OrthAlign, Inc.
Product/Product Line: OrthAlign Plus® System
FDA Regulation Medical Specialty: Neurological Devices - Neurological Surgical Devices
FDA Regulation Number: 882.4560
FDA Regulation Description Classification Name:
Stereotaxic Instrument
FDA Classification Product Code: OLO
FDA Classification Product Code Device Name:
Orthopedic Stereotaxic Instrument
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
In knee arthroplasty procedures, the device assists the surgeon in:
• Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. • Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia.
• Measuring the angles and gap distances between the femur and proximal tibia, for use in ligament balancing and establishing a reference line to assist in setting the rotation of the femoral implant, in primary or revision procedures.
In hip arthroplasty procedures, the device assists the surgeon in:
• Establishing the orientation of the anterior pelvic plane and determining the inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane, or to the anterior pelvic plane adjusted for pelvic tilt.
• Measuring the intraoperative change in leg length and offset.
In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:
• Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation
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