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510(k) K231657

AGILON® XO Shoulder Replacement System by Implantcast GmbH — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2024
Date Received
June 7, 2023
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 Implantcast GmbH

  • K252401 — implaFit® short stems (March 12, 2026)
  • K241944 — AGILON® XO Shoulder Replacement System (March 10, 2025)
  • K240391 — MUTARS® femoral stem cemented 160 mm and 200 mm (October 24, 2024)
  • K234044 — ACS® LD FB Knee System (September 6, 2024)
  • K240834 — EcoFit® short stem cementless cpTi (June 3, 2024)
  • K232371 — Actinia® hip stems (October 19, 2023)
  • K223103 — BethaLoc® stem cementless HA (June 20, 2023)
  • K222482 — AGILON XO Shoulder System (September 28, 2022)
  • K210678 — implaFit® hip stems (August 17, 2022)
  • K203420 — EcoFit® Hip System (February 3, 2021)

Other clearances for product code KWT

  • K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implant (December 1, 2025)
  • 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)
  • 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)
  • K192365 — Shoulder Innovations Total Shoulder System (November 29, 2019)
  • K191811 — Catalyst OrthoScience CSR Shoulder System (September 11, 2019)