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510(k) K222482

AGILON XO Shoulder System by Implantcast GmbH — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2022
Date Received
August 17, 2022
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)
  • K231657 — AGILON® XO Shoulder Replacement System (February 16, 2024)
  • K232371 — Actinia® hip stems (October 19, 2023)
  • K223103 — BethaLoc® stem cementless HA (June 20, 2023)
  • 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)
  • K231657 — AGILON® XO Shoulder Replacement System (February 16, 2024)
  • K223631 — Comprehensive Segmental Revision System(SRS) (July 12, 2023)
  • 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)