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21 C.F.R. § 888.3330   Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices

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§ 888.3330   Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a) Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§888.3027).

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §888.3.