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510(k) K213615

Shoulder Innovations Total Shoulder System by Shoulder Innovations, Inc. — Product Code PKC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2022
Date Received
November 15, 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 Shoulder Innovations, Inc.

  • K252516 — N22 EZ Glenosphere (January 15, 2026)
  • K252221 — Inset Reverse Total Shoulder System (September 26, 2025)
  • K241817 — InSet Total Shoulder System (February 11, 2025)
  • K210533 — Inset Reverse Total Shoulder System (August 20, 2021)
  • K192365 — Shoulder Innovations Total Shoulder System (November 29, 2019)
  • K173824 — Humeral Short Stem System (October 23, 2018)
  • K111596 — TOTAL SHOULDER SYSTEM (July 5, 2011)
  • K110905 — TOTAL SHOULDER SYSTEM (May 24, 2011)
  • K102670 — TOTAL SHOULDER SYSTEM (January 24, 2011)

Other clearances for product code PKC

  • 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)
  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K203108 — Ignite Stemless Anatomic Shoulder System (July 16, 2021)
  • K201391 — Easytech® Anatomical Shoulder System (February 16, 2021)
  • K203100 — Arthrex Eclipse Titanium Humeral Head (November 20, 2020)