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510(k) K251686

Tornier Humeral Reconstruction System Max (Tornier HRS Max) by Tornier, Inc. — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2025
Date Received
June 2, 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 Tornier, Inc.

  • K252788 — Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (January 8, 2026)
  • K232265 — BLUEPRINT™ Patient Specific Instrumentation (February 21, 2024)
  • K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail (October 31, 2023)
  • K222510 — Blueprint Mixed Reality system (January 20, 2023)
  • DEN220012 — Tornier Pyrocarbon Humeral Head (December 16, 2022)
  • K220914 — Tornier Perform Humeral System – Fracture (October 14, 2022)
  • K220418 — Tornier Perform Humeral System – Stemless (September 14, 2022)
  • K211359 — Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient (November 12, 2021)
  • K213124 — Tomier Perform™ Reversed Glenoid Cannulated Glenospheres (October 26, 2021)
  • K203315 — BLUEPRINT™ Patient Specific Instrumentation (April 15, 2021)

Other clearances for product code KWT

  • K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implant (December 1, 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)