K Number
K960425
Device Name
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
Manufacturer
Date Cleared
1996-10-03

(248 days)

Product Code
Regulation Number
888.3350
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information

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§ 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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