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510(k) K133834

DEPUY GLOBAL UNITE SHOULDER SYSTEM by Depuy(Ireland) — Product Code KWS

K133834 is an FDA 510(k) premarket notification submitted by Depuy(Ireland) for the device "DEPUY GLOBAL UNITE SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 3, 2014. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Depuy(Ireland) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2014
Date Received
December 17, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Other clearances by Depuy(Ireland)

  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K192855 — DELTA XTEND(TM) Reverse Shoulder System (February 24, 2020)
  • K190344 — DePuy Corail AMT Hip Prosthesis (November 1, 2019)
  • K191779 — Attune Revision LPS Inserts (October 8, 2019)
  • K192448 — Delta Xtend Revers Shoulder System (October 4, 2019)
  • K183077 — Delta Xtend Reverse Shoulder System (May 17, 2019)
  • K170806 — ATTUNE Cemented Tibial Base, Fixed Bearing (June 15, 2017)
  • K160907 — DePuy Actis DuoFix Hip Prosthesis (July 19, 2016)
  • K160700 — ATTUNE Revision Knee System (June 10, 2016)
  • K140881 — DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS (February 13, 2015)

Other clearances for product code KWS

  • K254084 — AETOS Shoulder System - CONCELOC Glenoids (April 6, 2026)
  • K252418 — Catalyst F1x Shoulder System (November 6, 2025)
  • K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (October 29, 2025)
  • K241292 — MyShoulder Planner (5.3SSWPL) (January 30, 2025)
  • K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral Sys (December 6, 2024)
  • K241609 — Tornier Humeral Reconstruction System (Tornier HRS) (September 10, 2024)
  • K230513 — Arthrex Univers Apex OptiFit Humeral Stem (September 26, 2023)
  • K222592 — AltiVate® Anatomic Shoulder AG e+™ with Markers (June 23, 2023)
  • K230572 — AETOS Shoulder System (June 7, 2023)
  • K220847 — AETOS Shoulder System (January 3, 2023)

FDA data resources