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510(k) K212683

GLOBAL ICON Stemless Shoulder System by Depuy(Ireland) — Product Code PKC

K212683 is an FDA 510(k) premarket notification submitted by Depuy(Ireland) for the device "GLOBAL ICON Stemless Shoulder System". The FDA issued a decision of Substantially Equivalent on January 19, 2022. The device falls under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained), 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
January 19, 2022
Date Received
August 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Replacement of the humeral head for total anatomic shoulder arthroplasty

Other clearances by Depuy(Ireland)

  • 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)
  • K133834 — DEPUY GLOBAL UNITE SHOULDER SYSTEM (April 3, 2014)

Other clearances for product code PKC

  • K254154 — FX V135 EASYTECH® Shoulder System (May 1, 2026)
  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K243248 — INHANCE INTACT™ (December 23, 2024)
  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K221758 — SMR Stemless Anatomic (March 17, 2023)
  • K220418 — Tornier Perform Humeral System – Stemless (September 14, 2022)
  • K213615 — Shoulder Innovations Total Shoulder System (March 11, 2022)
  • K203108 — Ignite Stemless Anatomic Shoulder System (July 16, 2021)
  • K201391 — Easytech® Anatomical Shoulder System (February 16, 2021)

FDA data resources