Lombardi Gap Balancing Femoral Tibial Spreader – Large with Diamond Cut Pads
Adolph V. Lombardi Jr., MD
Designed to help separate the femur and tibia during total knee procedures, with the pads being parallel when the scale shows 20 mm of separation
The scale on the spreader handle helps to accurately gauge the gap, and makes it possible for two spreaders to be used to assist in balancing ligaments.
This device is not intended to provide quantitative measurements and does not incorporate a measuring function as defined under Regulation (EU) 2017/745 (MDR).
Any scales, markings, or visual indicators present on the device are provided solely for reference and orientation purposes to support general use. These indicators are not calibrated against traceable standards and have not been validated for accuracy, precision, or repeatability.
Accordingly, values derived from these markings shall be considered approximate only and must not be used where accurate or traceable measurements are required for clinical decision-making, diagnosis, or other applications requiring defined metrological performance.
Users shall rely only on devices specifically intended and validated for measurement when quantitative accuracy is required.