Cleared Special

K110708 - EQUINOXE REVERSE SHOULDER COMPRESSION S...

K110708 is the FDA 510(k) clearance for EQUINOXE REVERSE SHOULDER COMPRESSION S... by Exactech, Inc.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Special 510(k) pathway after a 18-day FDA review.

K110708 · Exactech, Inc. · Orthopedic device
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Apr 2011
Decision
18d
Days
Class 2
Risk

K110708 is an FDA 510(k) clearance for the EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUP.... 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 April 1, 2011 after a review of 18 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 Exactech, Inc. devices

Submission Details

510(k) Number K110708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2011
Decision Date April 01, 2011
Days to Decision 18 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
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 K110708.
SMR REVERSE SHOULDER SYSTEM
K110598 · Lima Corporate S.P.A. · Aug 2011
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
K111061 · Encore Medical, L.P. · Jul 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K110599 · Tornier, Inc. · Jun 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
K103208 · Encore Medical, L.P. · Jan 2011
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)
K102951 · Exactech, Inc. · Nov 2010
BIO-MODULAR REVERSE SHOLDER
K093803 · Biomet Manufacturing Corp · Oct 2010