Cleared Traditional

K063569 - EQUINOXE REVERSE SHOULDER SYSTEM

K063569 is the FDA 510(k) clearance for EQUINOXE REVERSE SHOULDER SYSTEM by Exactech, Inc.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K063569 · Exactech, Inc. · Orthopedic device
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Feb 2007
Decision
86d
Days
Class 2
Risk

K063569 is an FDA 510(k) clearance for the EQUINOXE REVERSE SHOULDER SYSTEM. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on February 23, 2007 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Exactech, Inc. devices

Submission Details

510(k) Number K063569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2006
Decision Date February 23, 2007
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.
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 - PHX Shoulder Prosthesis, Reverse Configuration

All 180
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K063569.
COMPREHENSIVE RS SHOULDER SYSTEM
K072804 · Biomet Manufacturing Corp · Dec 2007
AEQUALIS REVERSED ADAPTER
K071948 · Tornier · Oct 2007
DELTA XTEND REVERSE SHOULDER MODULAR STEM
K071379 · DePuy Orthopaedics, Inc. · Sep 2007
DELTA XTEND REVERSE SHOULDER SYSTEM
K062250 · DePuy Orthopaedics, Inc. · Feb 2007
DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
K062116 · DePuy Orthopaedics, Inc. · Aug 2006
AEQUALIS REVERSED PROSTHESIS
K061439 · Tornier · Jul 2006