Cleared Traditional

K241609 - Tornier Humeral Reconstruction System (...

K241609 is an FDA 510(k) clearance for Tornier Humeral Reconstruction System (..., manufactured by Stryker Corporation (Tornier, Inc.). The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K241609 · Stryker Corporation (Tornier, Inc.) · Orthopedic device
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Sep 2024
Decision
97d
Days
Class 2
Risk

K241609 is an FDA 510(k) clearance for the Tornier Humeral Reconstruction System (Tornier HRS). Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Stryker Corporation (Tornier, Inc.) (Bloomington, US). The FDA issued a Cleared decision on September 10, 2024 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corporation (Tornier, Inc.) devices

FDA 510(k) Submission Details - K241609

510(k) Number K241609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2024
Decision Date September 10, 2024
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 156
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K241609.
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K252416 · Smith & Nephew, Inc. · Oct 2025
MyShoulder Planner (5.3SSWPL)
K241292 · Medacta International S.A. · Jan 2025
Tornier Humeral Reconstruction System (Tornier HRS)
K241878 · Stryker Corporation (Tornier, Inc.) · Dec 2024
Arthrex Univers Apex OptiFit Humeral Stem
K230513 · Arthrex, Inc. · Sep 2023
AltiVate® Anatomic Shoulder AG e+™ with Markers
K222592 · Encore Medical, L.P. · Jun 2023
AETOS Shoulder System
K230572 · Smith & Nephew, Inc. · Jun 2023