Cleared Special

K140904 - RSP MONOBLOCK STEM WITH P2 COATING

K140904 is the FDA 510(k) clearance for RSP MONOBLOCK STEM WITH P2 COATING by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Special 510(k) pathway after a 27-day FDA review.

K140904 · Encore Medical, L.P. · Orthopedic device
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May 2014
Decision
27d
Days
Class 2
Risk

K140904 is an FDA 510(k) clearance for the RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6. 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 May 6, 2014 after a review of 27 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 Encore Medical, L.P. devices

Submission Details

510(k) Number K140904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2014
Decision Date May 06, 2014
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 K140904.
POROUS COATED COMPREHENSIVE FRACTURE STEMS
K140652 · Biomet Manufacturing Corp · Jul 2014
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
K141029 · Tornier, Inc. · Jun 2014
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K133378 · Zimmer, Inc. · May 2014
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
K130550 · Encore Medical, L.P. · Mar 2014
REUNION RSA SHOULDER SYSTEM
K130895 · Howmedica Osteonics Corp. · Dec 2013
COMPREHENSIVE CONVERTIBLE GLENOID
K130390 · Biomet Manufacturing, Inc. · Oct 2013