Global Total Shoulder

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K914695 ↗

FDA Product Code

KWT

Device Class

Class II

Regulation

21 CFR Part 888.3650

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What conditions is the Global Total Shoulder designed to treat?

  The Global Total Shoulder is specifically designed to replace the natural shoulder joint in patients suffering from degenerative joint disease, severe osteoarthritis, or traumatic injuries. It provides a durable, load-bearing joint replacement to restore shoulder function and alleviate chronic pain caused by these conditions.

• How is the Global Total Shoulder supplied and intended for use?

  This device is supplied sterile and intended for single-use in orthopedic surgical procedures. It must be used in approved surgical settings while adhering to standard aseptic techniques. Each component is engineered for one-time use to ensure patient safety and minimize infection risk.

• Is the Global Total Shoulder reusable, or is it meant for one-time use?

  The Global Total Shoulder is explicitly designed for single-use only. Reusing orthopedic implants like this increases the risk of infection, mechanical failure, and compromised patient outcomes. The sterile packaging and FDA clearance reflect its intended one-time surgical application.

• What components make up the Global Total Shoulder system?

  The system consists of three primary components: a humeral stem (fitted into the humerus bone), a metallic head (replicating the ball of the shoulder joint), and a polyethylene glenoid component (lining the socket of the shoulder blade). Together, these restore the natural ball-and-socket mechanics of the shoulder.

• How should the Global Total Shoulder be stored before use?

  The device must be stored according to the manufacturer’s guidelines to maintain sterility and integrity. This includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the components remain free from contamination and damage until surgery.