§ 888.4505 - Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.

§ 888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.

(a) Identification. Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9. The special controls for this device are:

(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position and place the implant.

(2) The patient contacting components of the device must be demonstrated to be biocompatible.

(3) Labeling must include:

(i) Identification of implant(s) and instruments which have been validated for use together; and

(ii) Validated methods and instructions for reprocessing any reusable parts.

[84 FR 57321, Oct. 25, 2019, as amended at 85 FR 44188, July 22, 2020]