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510(k) K220418

Tornier Perform Humeral System – Stemless by Tornier, Inc. — Product Code PKC

K220418 is an FDA 510(k) premarket notification submitted by Tornier, Inc. for the device "Tornier Perform Humeral System – Stemless". The FDA issued a decision of Substantially Equivalent on September 14, 2022. The device falls under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained), a Class II device regulated under 21 CFR 888.3660. Tornier, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2022
Date Received
February 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Replacement of the humeral head for total anatomic shoulder arthroplasty

Other clearances by Tornier, Inc.

  • K252788 — Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (January 8, 2026)
  • K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max) (October 30, 2025)
  • 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)
  • 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 PKC

  • K254154 — FX V135 EASYTECH® Shoulder System (May 1, 2026)
  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K243248 — INHANCE INTACT™ (December 23, 2024)
  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K221758 — SMR Stemless Anatomic (March 17, 2023)
  • K213615 — Shoulder Innovations Total Shoulder System (March 11, 2022)
  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K203108 — Ignite Stemless Anatomic Shoulder System (July 16, 2021)
  • K201391 — Easytech® Anatomical Shoulder System (February 16, 2021)

FDA data resources