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510(k) K192365

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2019
Date Received
August 30, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3650
Review Panel
OR
Submission Type

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)
  • K213615 — Shoulder Innovations Total Shoulder System (March 11, 2022)
  • K210533 — Inset Reverse Total Shoulder System (August 20, 2021)
  • 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 KWT

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  • K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max) (October 30, 2025)
  • K241944 — AGILON® XO Shoulder Replacement System (March 10, 2025)
  • K241817 — InSet Total Shoulder System (February 11, 2025)
  • K231657 — AGILON® XO Shoulder Replacement System (February 16, 2024)
  • K223631 — Comprehensive Segmental Revision System(SRS) (July 12, 2023)
  • K222482 — AGILON XO Shoulder System (September 28, 2022)
  • K210899 — LINK Embrace Shoulder System- Anatomical Configuration (June 21, 2021)
  • K191698 — TiN Coated Humeral Head (July 16, 2020)
  • K191811 — Catalyst OrthoScience CSR Shoulder System (September 11, 2019)