Vendor/Manufacturer: Stryker
Product/Product Line: Accolade® II Femoral Hip System
Vendor/Manufacturer Catalog #: 6720-0127
Global Unique Device (GUD) Primary Device Identifier Number: 04546540664440
Global Unique Device (GUD) Device Description:
132 Degree Neck Angle Hip Stem
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Coated hip femur prosthesis, modular
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3358
FDA Regulation Description Classification Name:
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
FDA Classification Product Code(s): JDI, KWL, KWY, KWZ, LPH, LWJ, LZO, MAY, MBL, MEH
FDA Classification Product Code Device Name(s):
JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWL: Prosthesis, hip, hemi-, femoral, metal
KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented
LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAY: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBL: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
The Stryker Accolade® II Femoral Hip System is
SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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