DePuy Synthes CORAIL® Total Hip System. Catalog #3L93709

Vendor/Manufacturer: DePuy Synthes

Product/Product Line: CORAIL® Total Hip System

Vendor/Manufacturer Catalog #: 3L93709

Global Unique Device (GUD) Primary Device Identifier Number: 10603295168867

Global Unique Device (GUD) Device Description:

CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM 12/14 AMT 125 DEGREES KLA SIZE 9 HA COATED HIGH OFFSET COLLAR

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: MEH, KWA, LWJ, LZO

FDA Classification Product Code Device Name:

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

KWA: Prosthesis, hip, semi-constrained (metal uncemented acetabular component)

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

LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

FDA Premarket Submission: K192946 , K190344 , K070554 , K042992