21 CFR §888.4515

1. (a)Identification. Orthopedic manual surgical instrumentation for use with total disc replacement devices are non-powered hand-held devices designed specifically for use with a total disc replacement device and interface with the associated implant for the purpose of insertion, removal, placement, or repositioning, or to cut, rasp, or create a defect specific to the features of the associated implant. This type of device includes instruments specific to the geometry of the implant.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
   2. (2)The patient contacting components of the device must be demonstrated to be biocompatible.
   3. (3)Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
   4. (4)Labeling must include:
      1. (i)Identification of implant(s) and instruments which have been validated for use together; and
      2. (ii)Validated methods and instructions for reprocessing any reusable parts.