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510(k) K250713

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants by Exactech, Inc. — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2025
Date Received
March 10, 2025
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 Exactech, Inc.

  • K243448 — Equinoxe® Shoulder System (August 1, 2025)
  • K243275 — Equinoxe® Scapula Fracture System (June 26, 2025)
  • K243839 — Alteon® HA Femoral Stems (March 10, 2025)
  • K240393 — Exactech® TRULIANT® Knee System (October 3, 2024)
  • K233482 — Equinoxe® Central Screw Baseplate System (July 18, 2024)
  • K230717 — Exactech® Vantage® Total Ankle System (October 12, 2023)
  • K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (September 25, 2023)
  • K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (September 14, 2023)
  • K232002 — Vantage® Total Ankle System (September 11, 2023)
  • K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (July 17, 2023)

Other clearances for product code KWT

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