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510(k) K191698

TiN Coated Humeral Head by Fx Shoulder USA, Inc. — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2020
Date Received
June 25, 2019
Clearance Type
Traditional
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 Fx Shoulder USA, Inc.

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  • K222936 — Humeris® 135 Shoulder System (November 7, 2022)
  • K213117 — FX V135 Shoulder Prosthesis (June 7, 2022)
  • K210790 — Lateralized and Augmented Baseplates (August 25, 2021)
  • K201391 — Easytech® Anatomical Shoulder System (February 16, 2021)
  • K191146 — Humelock TiN Coated Glenosphere (July 15, 2020)
  • K193394 — Humeral Cup Stability & Humeral Cup 135/145o Stability (April 29, 2020)
  • K192799 — Glenoid Baseplate with Screw (February 21, 2020)
  • K192206 — 32mm Glenosphere and Humeral Cup (October 8, 2019)

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  • 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)
  • K192365 — Shoulder Innovations Total Shoulder System (November 29, 2019)
  • K191811 — Catalyst OrthoScience CSR Shoulder System (September 11, 2019)