Zimmer Biomet Taperloc® Complete Hip System. Catalog #51-103110

Vendor/Manufacturer: Zimmer Biomet

Product/Product Line: Taperloc® Complete Hip System

Vendor/Manufacturer Catalog #: 51-103110

Global Unique Device (GUD) Primary Device Identifier Number: 00880304489745

Global Unique Device (GUD) Device Description:

Taperloc Complete Reduced Distal Stem, Size 11

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: 888.3353

FDA Regulation Description Classification Name:

Hip joint metal/ceramic/polymer semi constrained cemented or nonporous uncemented prosthesis

FDA Classification Product Code(s): JDI, KWL, KWY, KWZ, LPH, LWJ, LZO, MAY, 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

MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

FDA Premarket Submission(s): K200196 The Zimmer Biomet Taperloc® Complete Hip System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. All previous versions of the Taperloc® Complete Hip Stems

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