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. § 888.3358

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

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(a) Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

(b) Classification. Class II.

[58 FR 3228, Jan. 8, 1993]
Notes of Decisions
Cited in 2 cases, 1997–2014 · leading case: Redd v. DePuy Orthopaedics, Inc., 48 F. Supp. 3d 1261 (E.D. Mo. 2014).
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Redd v. DePuy Orthopaedics, Inc., 48 F. Supp. 3d 1261 (E.D. Mo. 2014). · cites it 3× “8, 1993) (codified at 21 C.F.R. § 888.3358 ). The identification or classification of the Total Hip System is not enough to trigger federal preemption.”
Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir. 1997). “On June 10, 1992, the FDA granted Howmedica permission to market the PCA hip when used without cement under the premarket notification procedure.”
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.