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510(k) K173824

Humeral Short Stem System by Shoulder Innovations, Inc. — Product Code MBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2018
Date Received
December 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3670
Review Panel
OR
Submission Type

Other clearances by Shoulder Innovations, Inc.

  • K252516 — N22 EZ Glenosphere (January 15, 2026)
  • K252221 — Inset Reverse Total Shoulder System (September 26, 2025)
  • K241817 — InSet Total Shoulder System (February 11, 2025)
  • K213615 — Shoulder Innovations Total Shoulder System (March 11, 2022)
  • K210533 — Inset Reverse Total Shoulder System (August 20, 2021)
  • K192365 — Shoulder Innovations Total Shoulder System (November 29, 2019)
  • K111596 — TOTAL SHOULDER SYSTEM (July 5, 2011)
  • K110905 — TOTAL SHOULDER SYSTEM (May 24, 2011)
  • K102670 — TOTAL SHOULDER SYSTEM (January 24, 2011)

Other clearances for product code MBF

  • K251098 — Identity Revision Humeral Stems (August 11, 2025)
  • K250848 — Identity Shoulder System (July 2, 2025)
  • K240876 — Identity Shoulder System (June 12, 2024)
  • K233712 — PRIMA Humeral System; PRIMA TT Glenoid (January 11, 2024)
  • K231099 — SMR Hybrid Glenoid System (December 21, 2023)
  • K230831 — INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (November 13, 2023)
  • K231516 — INHANCE™ Shoulder System, Sterile Single Use Instrumentation (July 21, 2023)
  • K223876 — SMR Shoulder System (February 3, 2023)
  • K222427 — PRIMA TT Glenoid (October 6, 2022)
  • K213856 — Identity Shoulder System (September 15, 2022)