Cleared Special

K113121 - COMPREHENSIVE REVERSE SHOULDER

K113121 is the FDA 510(k) clearance for COMPREHENSIVE REVERSE SHOULDER by Biomet Manufacturing, Inc.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Special 510(k) pathway after a 56-day FDA review.

K113121 · Biomet Manufacturing, Inc. · Orthopedic device
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Dec 2011
Decision
56d
Days
Class 2
Risk

K113121 is an FDA 510(k) clearance for the COMPREHENSIVE REVERSE SHOULDER. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 16, 2011 after a review of 56 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 Biomet Manufacturing, Inc. devices

Submission Details

510(k) Number K113121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2011
Decision Date December 16, 2011
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 K113121.
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
K120121 · Biomet, Inc. · Feb 2012
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
K113069 · Biomet Manufacturing Corp · Jan 2012
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
K113523 · Lima Corporate S.P.A. · Dec 2011
RSP GLENOID BASEPLATE POROUS COATED
K112069 · Encore Medical, L.P. · Nov 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K112615 · Tornier, Inc. · Oct 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
K111735 · Encore Medical, L.P. · Oct 2011