C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 888—ORTHOPEDIC DEVICES › Subpart D—Prosthetic Devices

21 C.F.R. § 888.3027

Polymethylmethacrylate (PMMA) bone cement

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(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]
Notes of Decisions
Cited in 4 cases, 1993–2008 · leading case: Reiter v. Zimmer, Inc., 830 F. Supp. 199 (S.D.N.Y. 1993).
Sort: Relevance Newest Treatment
Reiter v. Zimmer, Inc., 830 F. Supp. 199 (S.D.N.Y. 1993). · cites it 4× “21 C.F.R. § 888.3027 (b). 2 Certain FDA approvals are required before a Class III device may be commercially distributed.”
Scott v. Pfizer Inc., 249 F.R.D. 248 (E.D. Tex. 2008). “5; see also 21 C.F.R. 888.3027 The Court will accordingly treat the Simplex at issue in Mr.”
Carol Jean Brooks v. Howmedica, Inc., 236 F.3d 956 (8th Cir. 2001). · cites it 2× “§§ 360e(b)(1)(A), 360j(l)(3)(A); 21 C.F.R. § 888.3027 (establishing, in combination, that drugs reclassified as devices in 1976 — such as Simplex — are considered PMA-compliant).”
Brooks v. Howmedica, 236 F.3d 956 (8th Cir. 2001). “360e(b)(1)(A), 360j(l)(3)(A); 21 C.F.R. 888.3027 (establishing, in combination, that drugs reclassified as devices in 1976 -- such as Simplex -- are considered PMA-compliant).”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.