Shoulder Innovations Total Shoulder System— 510(k) K213615

Name: FDA 510(k) clearance K213615
Creator: U.S. Food and Drug Administration
Published: 2022-03-11

Substantially Equivalent

Shoulder Innovations, Inc.

FDA 510(k) clearance K213615 for Shoulder Innovations Total Shoulder System, Substantially Equivalent on 2022-03-11. Applicant: Shoulder Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Shoulder Innovations, Inc.
Product code: Code PKC
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2021-11-15
Decision date: 2022-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holland, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKC

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K254154 — FX V135 EASYTECH® Shoulder System2026-05-01
K252129 — AETOS Shoulder System Stemless Humeral Prosthesis2025-10-03
K243248 — INHANCE INTACT2024-12-23
K241873 — OsseoFit Stemless Shoulder System2024-12-11
K240716 — AETOS Shoulder System Stemless Humeral Prosthesis2024-11-20

More clearances from Shoulder Innovations, Inc.

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K262173 — N22 Offset Humeral Head2026-09-08
K254128 — InSet Reverse Total Shoulder System2026-04-13
K252516 — N22 EZ Glenosphere2026-01-15
K252221 — Inset Reverse Total Shoulder System2025-09-26
K241817 — InSet Total Shoulder System2025-02-11

Adverse events under product code PKC

product code PKC

Injury: 258
Total: 258

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.