Cleared Traditional

K133834 - DEPUY GLOBAL UNITE SHOULDER SYSTEM

K133834 is an FDA 510(k) clearance for DEPUY GLOBAL UNITE SHOULDER SYSTEM, manufactured by Depuy(Ireland). The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K133834 · Depuy(Ireland) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
107d
Days
Class 2
Risk

K133834 is an FDA 510(k) clearance for the DEPUY GLOBAL UNITE SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Depuy(Ireland) (Co. Cork, IE). The FDA issued a Cleared decision on April 3, 2014 after a review of 107 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 Depuy(Ireland) devices

FDA 510(k) Submission Details - K133834

510(k) Number K133834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2013
Decision Date April 03, 2014
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 158
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K133834.
Aequalis PerFORM+ Shoulder System
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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