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. § 888.3560

Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

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(a) Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

(b) Classification. Class II.

Notes of Decisions
Cited in 5 cases, 1993–1995 · leading case: Ginochio v. Surgikos, Inc., 864 F. Supp. 948 (N.D. Cal. 1994).
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Ginochio v. Surgikos, Inc., 864 F. Supp. 948 (N.D. Cal. 1994). · cites it 6× “1(d) applies, plaintiffs claims are preempted because 21 C.F.R. § 888.3560 specifically regulates these devices and several other regulations also apply to them.”
Elbert v. Howmedica, Inc., 841 F. Supp. 327 (D. Haw. 1993). · cites it 2× “The relevant regulation is 21 C.F.R. § 888.3560 (1992) entitled “Knee Joint Patello-femorotibial polymer/metal/polymer semi-constrained cemented prosthesis.”
Parenteau v. Johnson & Johnson Orthopedics, Inc., 856 F. Supp. 61 (D.N.H. 1994). · cites it 2× “A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint.”
Oliver v. Johnson & Johnson, Inc., 863 F. Supp. 251 (W.D. Pa. 1994). “21 C.F.R. § 888.3560 . Therefore, it is one that “is or eventually will be subject to special controls.”
Dow v. Baxter Healthcare Corp., 899 F. Supp. 822 (D. Mass. 1995). “The court held that the identification and classification regulations at 21 C.F.R. § 888.3560 regarding knee prosthetic devices, as well as the general controls to which all Class II devices are subject, did not regulate the design of the knee prosthesis at issue.”
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