21 C.F.R. § 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.
Notes of Decisions
Cited in 1
case, 1997–1997 · leading case: Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir. 1997).
Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir. 1997). “33686, 33707 (codified at 21 C.F.R. § 888.3350 ). At that time, the FDA had determined that classification as a class III device was “not necessary to provide reasonable assurance of the safety and effectiveness of the device.”
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