Global Total Shoulder W/Dupont Enhanced UHMWPE

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Global(Tm) Total Shoulder W/Dupont Enhanced Uhmwpe

510(k) Number

K914000 ↗

FDA Product Code

KWT

Device Class

Class II

Regulation

21 CFR Part 888.3650

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Delta Shoulder

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  Class II

  FDA 510(k) K860594 Active Cleared 14 Mar 1986

• Porocoat (R) Proximal Femoral Third Prosthesis

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  FDA 510(k) K872025 Active Cleared 18 Aug 1987

• Cobalt Chrome Gemini

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  FDA 510(k) K934909 Active Cleared 28 Apr 1994

• Depuy Titanium Cross Pin Fixation System

  Class II

  FDA 510(k) K954630 Active Cleared 13 Dec 1995

• Depuy Cannulated Cross Pin Screw System

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  FDA 510(k) K963973 Active Cleared 16 Dec 1996

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• What is the Global Total Shoulder W/Dupont Enhanced UHMWPE used for?

  The Global Total Shoulder W/Dupont Enhanced UHMWPE is a non-constrained, metal/polymer cemented shoulder prosthesis designed for use in shoulder arthroplasty procedures to replace damaged or diseased shoulder joints.

• How is the Global Total Shoulder prosthesis supplied?

  The device is supplied by DePuy, Inc. and is available in various sizes to accommodate different patient anatomies. It is intended for cemented implantation during shoulder surgery.

• What is the regulatory status of the Global Total Shoulder prosthesis?

  The Global Total Shoulder W/Dupont Enhanced UHMWPE received FDA 510(k) clearance on December 4, 1991. It is classified as Class II under product code KWT with special controls.

• Is the Global Total Shoulder prosthesis reusable?

  The device information does not specify whether the Global Total Shoulder prosthesis is single-use or reusable. For proper handling and reuse instructions, please consult the manufacturer's guidelines or product documentation.