Cleared Traditional

K103251 - DUOCENTRIC REVERSED

K103251 is an FDA 510(k) clearance for DUOCENTRIC REVERSED, manufactured by Aston Medical. The device is a Class 2 Orthopedic device with product code PHX cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K103251 · Aston Medical · Orthopedic device
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Oct 2011
Decision
359d
Days
Class 2
Risk

K103251 is an FDA 510(k) clearance for the DUOCENTRIC REVERSED. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Aston Medical (Santa Barbara, US). The FDA issued a Cleared decision on October 28, 2011 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aston Medical devices

FDA 510(k) Submission Details - K103251

510(k) Number K103251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2010
Decision Date October 28, 2011
Days to Decision 359 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 122d · This submission: 359d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 190
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K103251.
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
K113523 · Lima Corporate S.P.A. · Dec 2011
COMPREHENSIVE REVERSE SHOULDER
K113121 · Biomet Manufacturing, Inc. · 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
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