Cleared Traditional

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

K241878 · Stryker Corporation (Tornier, Inc.) · Orthopedic

Dec 2024

Decision

161d

Days

Class 2

Risk

About This 510(k) Submission

K241878 is an FDA 510(k) clearance for the Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem), a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Stryker Corporation (Tornier, Inc.) (Bloomington, US). The FDA issued a Cleared decision on December 6, 2024, 161 days after receiving the submission on June 28, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K241878 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2024
Decision Date	December 06, 2024
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660