PERFORM Humeral System Stem— 510(k) K201315

Name: FDA 510(k) clearance K201315
Creator: U.S. Food and Drug Administration
Published: 2020-09-11

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K201315 for PERFORM Humeral System Stem, Substantially Equivalent on 2020-09-11. Applicant: Tornier, Inc.. Device class: 2.

Clearance details

Applicant: Tornier, Inc.
Product code: Code PAO
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2020-05-18
Decision date: 2020-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

Download summary PDF View on FDA.gov ↗

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K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)2025-10-30
K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail2023-10-31
K220914 — Tornier Perform Humeral System Fracture2022-10-14

Adverse events under product code PAO

product code PAO

Injury: 273
Total: 273

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K201315

K-number listed on FDA's recall record

Z-3309-2024 — Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplastyClass II·Ongoing·Tornier, Inc·20240829

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201315.

Data sourced from openFDA. This site is unofficial and independent of the FDA.