Cleared Traditional

DUOCENTRIC REVERSED SHOULDER PROSTHESIS (K133462) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133462 · Aston Medical · Orthopedic device
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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

Submission Details

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.

Device Classification

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 92
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K133462.
Arthrex VaultLock Glenoid
K161108 · Arthrex, Inc. · Aug 2016
Arthrex Univers Apex, Size 5 Stem
K153115 · Arthrex, Inc. · Nov 2015
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · Exactech, Inc. · Feb 2014
ARTHREX UNIVERS APEX
K131633 · Arthrex, Inc. · Sep 2013
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · Arthrex, Inc. · May 2013
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
K121220 · Exactech, Inc. · Nov 2012