Cleared Traditional

K111629 - TURON RSP SOCKET SHELL-NEUTRAL MODEL 50...

K111629 is the FDA 510(k) clearance for TURON RSP SOCKET SHELL-NEUTRAL MODEL 50... by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K111629 · Encore Medical, L.P. · Orthopedic device
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Sep 2011
Decision
95d
Days
Class 2
Risk

K111629 is an FDA 510(k) clearance for the TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSE.... 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 September 16, 2011 after a review of 95 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Encore Medical, L.P. devices

Submission Details

510(k) Number K111629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2011
Decision Date September 16, 2011
Days to Decision 95 days
Submission Type Traditional
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
27d faster than avg
Panel avg: 122d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K111629.
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
SMR REVERSE SHOULDER SYSTEM
K110598 · Lima Corporate S.P.A. · Aug 2011
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
K111061 · Encore Medical, L.P. · Jul 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K110599 · Tornier, Inc. · Jun 2011