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510(k) K201315

PERFORM Humeral System – Stem by Tornier, Inc. — Product Code PAO

K201315 is an FDA 510(k) premarket notification submitted by Tornier, Inc. for the device "PERFORM Humeral System – Stem". The FDA issued a decision of Substantially Equivalent on September 11, 2020. The device falls under product code PAO (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented), 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 11, 2020
Date Received
May 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.

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)
  • 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)

FDA data resources