Title 21 Part 888 → Subpart D → §888.3027

Title 21 → Chapter I → Subchapter H → Part 888 → Subpart D → §888.3027

Electronic Code of Federal Regulations e-CFR

Title 21 Part 888 → Subpart D → §888.3027

e-CFR data is current as of May 26, 2020

Title 21Chapter ISubchapter HPart 888Subpart D → §888.3027

Title 21: Food and Drugs
Subpart D—Prosthetic Devices

§888.3027   Polymethylmethacrylate (PMMA) bone cement.

(a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

[67 FR 46855, July 17, 2002]