21 CFR 888.3000 — Cap, Bone
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3000
Identification
A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.
Classification Rationale
Class I (general 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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JDT | Cap, Bone | 1 | 0 | Implant |
