Vendor/Manufacturer: Stryker
Product/Product Line: MDM® X3 Modular Dual Mobility Acetabular System
Vendor/Manufacturer Catalog #: 7236-2-244
Global Unique Device (GUD) Primary Device Identifier Number: 07613327315905
Global Unique Device (GUD) Device Description:
X3 Insert for MDM Liner
Global Medical Device Nomenclature (GMDN) Preferred Term Name: Non-constrained polyethylene acetabular liner Global Medical Device Nomenclature (GMDN) Definition: A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.
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, 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
MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
FDA Premarket Submission(s): K103233 , K093644 , K182468 The Stryker MDM® X3 Modular Dual Mobility Acetabular System is
SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Restoration® ADM System
For more information, please visit us at Infonomics.com