DePuy Synthes SUMMIT® Tapered Hip System. Catalog #1570-23-016

Vendor/Manufacturer: DePuy Synthes

Product/Product Line: SUMMIT® Tapered Hip System

Vendor/Manufacturer Catalog #: 1570-23-016

Global Unique Device (GUD) Primary Device Identifier Number: 10603295060550

Global Unique Device (GUD) Device Description:

SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 6 STD 127mm

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Uncoated hip femur prosthesis, modular

Global Medical Device Nomenclature (GMDN) Definition:

A sterile implantable principal component of a total hip prosthesis (femoral component) typically 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 not coated with materials 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 is intended to be performed with bone cement.

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3350

FDA Regulation Description Classification Name:

Hip joint metal/polymer semi-constrained cemented prosthesis

FDA Classification Product Codes: JDI, LWJ

FDA Classification Product Code Device Names:

JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

FDA Premarket Submission: K013352 , K023453 , K030122

The DePuy Synthes SUMMIT® Tapered Hip System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Endurance Total Hip System