DePuy DELTA XTEND™ Reverse Shoulder System. Catalog #130738203

Vendor/Manufacturer: DePuy Synthes

Product/Product Line: DELTA XTEND™ Reverse Shoulder System

Vendor/Manufacturer Catalog #: 130738203

Global Unique Device (GUD) Primary Device Identifier Number: 10603295027362

Global Unique Device (GUD) Device Description:

DELTA Xtend Standard Humeral PE Cup Dia38 /+3mm STD

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Total reverse shoulder prosthesis

Global Medical Device Nomenclature (GMDN) Definition:

A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3660

FDA Regulation Description Classification Name:

Shoulder joint metal/polymer semi-constrained cemented prosthesis

FDA Classification Product Code(s): HSD, KWS

FDA Classification Product Code Device Name(s):

HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

FDA Premarket Submission: K203694 , K062250 , K120174 , K192855 , K071379 , K192448 , K081620 The DePuy DELTA XTEND™ Reverse Shoulder System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Tornier Aequalis Reversed Fracture Shoulder Prosthesis