Cleared Traditional

EXACTECH EQUINOXE SHOULDER SYSTEM (K042021) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 91
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K042021.
SOLAR REUNION FRACTURE STEM
K062113 · Howmedica Osteonics Corp. · Oct 2006
DEPUY GLOBAL AP SHOULDER SYSTEM
K060874 · DePuy Orthopaedics, Inc. · Jun 2006
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
K052472 · DePuy Orthopaedics, Inc. · Oct 2005
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506 · Biomet, Inc. · Feb 2004
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · Smith & Nephew, Inc. · Mar 2003
ARTHREX UNIVERS FRACTURE PROSTHESIS
K020345 · Arthrex, Inc. · Sep 2002