§ 888.4510 Manual surgical instrument for appropriate patient selection for orthopedic implant.

(a) Identification. This device is an orthopedic manual surgical instrument used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for the orthopedic implant in terms of geometry, surgical technique and use of the device. (b) Classification. Class II (special controls). The special controls for this device are: (1) Technical specifications regarding geometry of the instruments must be identified and validated to demonstrate that the instruments accurately measure the critical geometry for patient selection of the intended orthopedic implant. (2) The use of the instruments is validated to demonstrate that the measurement process does not alter the patient anatomy which is being measured. (3) The patient contacting components of the device must be demonstrated to be biocompatible. (4) Labeling must include: (i) Identification of orthopedic implant(s) and instruments which have been validated for use together; and (ii) Validated methods and instructions for reprocessing any reusable parts.