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e-CFR data is current as of March 3, 2021

Title 21Chapter ISubchapter HPart 888Subpart D → §888.3350


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


§888.3350   Hip joint metal/polymer semi-constrained cemented prosthesis.

(a) Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§888.3027).

(b) Classification. Class II.

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