Cleared Special

K032679 - AEQUALIS SHOULDER FRACTURE SYSTEM

K032679 is an FDA 510(k) clearance for AEQUALIS SHOULDER FRACTURE SYSTEM, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code KWS cleared through the Special 510(k) pathway after a 108-day FDA review.

K032679 · Tornier · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
108d
Days
Class 2
Risk

K032679 is an FDA 510(k) clearance for the AEQUALIS SHOULDER FRACTURE 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 December 15, 2003 after a review of 108 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032679

510(k) Number K032679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2003
Decision Date December 15, 2003
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

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 191
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K032679.
AEQUALIS SHOULDER SYSTEM
K041339 · Tornier · Jun 2004
VERSA-DIAL HUMERAL HEAD
K040610 · Biomet Manufacturing, Inc. · Jun 2004
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506 · Biomet, Inc. · Feb 2004
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
K031449 · Implex Corp. · Sep 2003
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
K030259 · Centerplus Orthopedics, Inc. · Apr 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · Smith & Nephew, Inc. · Mar 2003
K032679 · AEQUALIS SHOULDER FRACTURE SYSTEM
Download PDF FDA Summary Tornier