Vendor/Manufacturer: Zimmer Biomet
Product/Product Line: Taperloc® Complete Hip System
Vendor/Manufacturer Catalog #: 51-100050
Global Unique Device (GUD) Primary Device Identifier Number: 00880304498167
Global Unique Device (GUD) Device Description:
Taperloc® Complete Full Profile Stem, Size 5
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:
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
FDA Classification Product Code(s): JDI, JDL, KWL, KWY, KWZ, LPH, LWJ, LZO, MAY, MEH
FDA Classification Product Code Device Name(s):
JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
JDL: Prosthesis, hip, semi-constrained (metal cemented acetabular component)
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
MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
FDA Premarket Submission(s): K120030 , K103755 The Zimmer Biomet Taperloc® Complete Full Profile Stem is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Zimmer Biomet Taperloc® Complete Stems
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