DEPUY GLOBAL UNITE SHOULDER SYSTEM— 510(k) K133834

Clearance details

Applicant

Depuy(Ireland)

Product code

Code KWS

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2013-12-17

Decision date

2014-04-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Co. Cork, IE

• K260721 — Tornier Perform Advanced Glenoid2026-07-22
• K254084 — AETOS Shoulder System - CONCELOC Glenoids2026-04-06
• K252418 — Catalyst F1x Shoulder System2025-11-06
• K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
• K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

• K212683 — GLOBAL ICON Stemless Shoulder System2022-01-19
• K192855 — DELTA XTEND(TM) Reverse Shoulder System2020-02-24
• K190344 — DePuy Corail AMT Hip Prosthesis2019-11-01
• K191779 — Attune Revision LPS Inserts2019-10-08
• K192448 — Delta Xtend Revers Shoulder System2019-10-04

Death

6

Injury

9,652

Malfunction

1,385

Other

1

Total

11,044

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1012-2018 — The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdfClass II·Terminated·DePuy Orthopaedics, Inc.·20171128

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133834.