Cleared Traditional

K133462 - DUOCENTRIC REVERSED SHOULDER PROSTHESIS

K133462 is an FDA 510(k) clearance for DUOCENTRIC REVERSED SHOULDER PROSTHESIS, manufactured by Aston Medical. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K133462 · Aston Medical · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2014
Decision
87d
Days
Class 2
Risk

K133462 is an FDA 510(k) clearance for the DUOCENTRIC REVERSED SHOULDER PROSTHESIS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Aston Medical (Santa Barbara, US). The FDA issued a Cleared decision on February 7, 2014 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aston Medical devices

FDA 510(k) Submission Details - K133462

510(k) Number K133462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2013
Decision Date February 07, 2014
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 166
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K133462.
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
K142403 · Zimmer GmbH · Nov 2014
SMR TT METAL BACK GLENOID
K133349 · Lima Corporate S.P.A. · Jun 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · Exactech, Inc. · Feb 2014
REVERSE SHOULDER PROSTHESIS MONOBLOCK
K130048 · Encore Medical, L.P. · Oct 2013
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
K131559 · Materialise NV · Sep 2013
ARTHREX UNIVERS APEX
K131633 · Arthrex, Inc. · Sep 2013