Cleared Traditional

K042021 - EXACTECH EQUINOXE SHOULDER SYSTEM

K042021 is an FDA 510(k) clearance for EXACTECH EQUINOXE SHOULDER SYSTEM, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K042021 · Exactech, Inc. · Orthopedic device
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Oct 2004
Decision
90d
Days
Class 2
Risk

K042021 is an FDA 510(k) clearance for the EXACTECH EQUINOXE SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 26, 2004 after a review of 90 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 Exactech, Inc. devices

FDA 510(k) Submission Details - K042021

510(k) Number K042021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2004
Decision Date October 26, 2004
Days to Decision 90 days
Submission Type Traditional
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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 185
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K042021.
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
K043346 · Genesis Medical LLC · Jan 2005
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K043077 · Tornier · Dec 2004
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
K043061 · Zimmer Trabecular · Nov 2004
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