DJO Surgical (Enovis) AltiVate Reverse® Shoulder System. Catalog # 804-06-091

Vendor/Manufacturer: DJO Surgical (Enovis)

Product/Product Line: AltiVate Reverse® Shoulder System

Vendor/Manufacturer Catalog #: 804-06-091

Global Unique Device (GUD) Primary Device Identifier Number: 00888912648172

Global Unique Device (GUD) Device Description:

ALTIVATE REVERSE, IMPACTION FIXTURE SET SCREW

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Orthopaedic prosthesis implantation instrument, reusable

Global Medical Device Nomenclature (GMDN) Definition:

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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: