Cleared Special

K041339 - AEQUALIS SHOULDER SYSTEM

K041339 is the FDA 510(k) clearance for AEQUALIS SHOULDER SYSTEM by Tornier. It is a Class 2 Orthopedic device (product code KWS) cleared through the Special 510(k) pathway after a 28-day FDA review.

K041339 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
28d
Days
Class 2
Risk

K041339 is an FDA 510(k) clearance for the AEQUALIS SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Tornier (Montbonnot, FR). The FDA issued a Cleared decision on June 17, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tornier devices

Submission Details

510(k) Number K041339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2004
Decision Date June 17, 2004
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 152
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K041339.
ANATOMICAL SHOULDER KEELED GLENOID
K051623 · Zimmer GmbH · Jul 2005
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K043077 · Tornier · Dec 2004
EXACTECH EQUINOXE SHOULDER SYSTEM
K042021 · Exactech, Inc. · Oct 2004
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506 · Biomet, Inc. · Feb 2004
AEQUALIS SHOULDER FRACTURE SYSTEM
K032679 · Tornier · Dec 2003
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
K031449 · Implex Corp. · Sep 2003