Cleared Special

K100741 - REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM

K100741 is the FDA 510(k) clearance for REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Special 510(k) pathway after a 139-day FDA review.

K100741 · Encore Medical, L.P. · Orthopedic device
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Aug 2010
Decision
139d
Days
Class 2
Risk

K100741 is an FDA 510(k) clearance for the REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMER.... Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on August 2, 2010 after a review of 139 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Encore Medical, L.P. devices

Submission Details

510(k) Number K100741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2010
Decision Date August 02, 2010
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K100741.
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
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
K101909 · Exactech, Inc. · Aug 2010
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
K093275 · Exactech, Inc. · May 2010
AEQUALIS REVERSED SHOULDER PROSTHESIS
K100142 · Tornier · May 2010