Cleared Traditional

Tornier Humeral Reconstruction System Max (Tornier HRS Max)

K251686 · Tornier, Inc. · Orthopedic

Oct 2025

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K251686 is an FDA 510(k) clearance for the Tornier Humeral Reconstruction System Max (Tornier HRS Max), a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWT), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on October 30, 2025, 150 days after receiving the submission on June 2, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K251686 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2025
Decision Date	October 30, 2025
Days to Decision	150 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