Stryker Accolade® II Femoral Hip System. Catalog #6720-0127

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

FDA Premarket Submission(s): K182468 , K120578

The Stryker Accolade® II Femoral Hip System is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Stryker Trident® X3® Acetabular Inserts

2. Stryker Restoration ADM® and MDM® X3® Acetabular Inserts

3. Stryker Howmedica Osteonics Restoration Modular System

4. Stryker Howmedica Osteonics Accolade TMZF

For more information, please visit us at Infonomics.com