DJO Surgical (Enovis) AltiVate Reverse® Shoulder System. Catalog # 533-08-000

Vendor/Manufacturer: DJO Surgical (Enovis)

Product/Product Line: AltiVate Reverse® Shoulder System

Vendor/Manufacturer Catalog #: 533-08-000

Global Unique Device (GUD) Primary Device Identifier Number: 00190446257738

Global Unique Device (GUD) Device Description:

ALTIVATE REVERSE, SMALL SPACER 8mm

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 Codes: PHX, HSD, KWS

FDA Classification Product Code Device Names:

PHX: shoulder prosthesis, reverse configuration

HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

FDA Premarket Submission: K172351

The DJO Surgical (Enovis) AltiVate Reverse® Shoulder System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Zimmer Trabecular Metal Reverse

2. Reverse® Shoulder Prosthesis Monoblock

3. Encore Humeral Shoulder Stem

For more information, please visit us at Infonomics.com