Cleared Special

EXACTECH EQUINOXE, PLATFORM FRACTURE STEM (K101909) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101909 · Exactech, Inc. · Orthopedic device
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Aug 2010
Decision
25d
Days
Class 2
Risk

K101909 is an FDA 510(k) clearance for the EXACTECH EQUINOXE, PLATFORM FRACTURE STEM. 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 August 2, 2010 after a review of 25 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 K101909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2010
Decision Date August 02, 2010
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
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 138
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K101909.
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
K120121 · Biomet, Inc. · Feb 2012
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
K110708 · Exactech, Inc. · Apr 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
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
K093275 · Exactech, Inc. · May 2010
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
K092900 · Exactech, Inc. · Jan 2010
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
K082702 · Exactech, Inc. · Oct 2008