Cleared Traditional

ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K133378) - FDA 510(k) Clearance

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

K133378 · Zimmer, Inc. · Orthopedic device
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May 2014
Decision
189d
Days
Class 2
Risk

K133378 is an FDA 510(k) clearance for the ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 12, 2014 after a review of 189 days - an extended review 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: 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 Zimmer, Inc. devices

Submission Details

510(k) Number K133378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2013
Decision Date May 12, 2014
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 138
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K133378.
Exactech® Equinoxe® Preserve Stem
K162726 · Exactech, Inc. · Feb 2017
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
K150458 · Exactech, Inc. · May 2015
Univers Rivers Shoulder Prosthesis System
K142863 · Arthrex, Inc. · Nov 2014
REUNION RSA SHOULDER SYSTEM
K130895 · Howmedica Osteonics Corp. · Dec 2013
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT
K131575 · Exactech, Inc. · Jul 2013
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K130661 · Zimmer, Inc. · May 2013