Vendor/Manufacturer: DePuy Synthes
Product/Product Line: ACTIS Hip Prosthesis
Vendor/Manufacturer Catalog #: 1010-14-100
Global Unique Device (GUD) Primary Device Identifier Number: 10603295380863
Global Unique Device (GUD) Device Description:
ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLLAR SIZE 10
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Coated femoral stem prosthesis, modular
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. 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 Codes: LPH, KWL, MEH, KWY
FDA Classification Product Code Device Names:
LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWL: Prosthesis, hip, hemi-, femoral, metal
MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
FDA Premarket Submission: K150862
The Depuy ACTIS Hip Prosthesis is
SUBSTANTIALLY EQUIVALENT to the following products:
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