Cleared Special

K111061 - REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)

K111061 is an FDA 510(k) clearance for REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP), manufactured by Encore Medical, L.P.. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 93-day FDA review.

K111061 · Encore Medical, L.P. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
93d
Days
Class 2
Risk

K111061 is an FDA 510(k) clearance for the REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP). 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 July 20, 2011 after a review of 93 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.

FDA 510(k) Submission Details - K111061

510(k) Number K111061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2011
Decision Date July 20, 2011
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

PHX Device Classification - Class 2, Special Controls

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 206
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K111061.
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
K111735 · Encore Medical, L.P. · Oct 2011
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001
K111629 · Encore Medical, L.P. · Sep 2011
SMR REVERSE SHOULDER SYSTEM
K110598 · Lima Corporate S.P.A. · Aug 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K110599 · Tornier, Inc. · Jun 2011
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
K110708 · Exactech, Inc. · Apr 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
K103208 · Encore Medical, L.P. · Jan 2011
K111061 · REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
Download PDF FDA Summary Encore Medical, L.P.