21 CFR 888.3027
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.3027, § 888.3027 Polymethylmethacrylate (PMMA) bone cement, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91059
- Permanent ID
ys:prov:91059@1- SHA-256
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Full text
(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.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.