Cleared Traditional

InSet Total Shoulder System

K241817 · Shoulder Innovations, Inc. · Orthopedic

Feb 2025

Decision

232d

Days

Class 2

Risk

About This 510(k) Submission

K241817 is an FDA 510(k) clearance for the InSet Total Shoulder System, a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWT), submitted by Shoulder Innovations, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 11, 2025, 232 days after receiving the submission on June 24, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K241817 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2024
Decision Date	February 11, 2025
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3650