21 CFR 888.4505 — Instruments Designed For Press-Fit Osteochondral Implants
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4505
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.
Classification Rationale
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QBO | Instruments Designed For Press-Fit Osteochondral Implants | 2 | 2 |
Special Controls
QBO — Instruments Designed For Press-Fit Osteochondral Implants
*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.
eCFR
