Aequalis PerFORM+ Shoulder System— 510(k) K150583

Name: FDA 510(k) clearance K150583
Creator: U.S. Food and Drug Administration
Published: 2015-04-23

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K150583 for Aequalis PerFORM+ Shoulder System, Substantially Equivalent on 2015-04-23. Applicant: Tornier, Inc.. Device class: 2.

Clearance details

Applicant: Tornier, Inc.
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2015-03-09
Decision date: 2015-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWS

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K260721 — Tornier Perform Advanced Glenoid2026-07-22
K254084 — AETOS Shoulder System - CONCELOC Glenoids2026-04-06
K252418 — Catalyst F1x Shoulder System2025-11-06
K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

More clearances from Tornier, Inc.

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K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono)2026-01-08
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
K220418 — Tornier Perform Humeral System Stemless2022-09-14

Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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 →

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