Cleared Traditional

K152754 - COMPREHENSIVE VAULT RECONSTRUCTION SYST...

K152754 is the FDA 510(k) clearance for COMPREHENSIVE VAULT RECONSTRUCTION SYST... by Biomet Manufacturing Corp. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K152754 · Biomet Manufacturing Corp · Orthopedic device
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May 2016
Decision
235d
Days
Class 2
Risk

K152754 is an FDA 510(k) clearance for the COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS). Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on May 16, 2016 after a review of 235 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 Biomet Manufacturing Corp devices

Submission Details

510(k) Number K152754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2015
Decision Date May 16, 2016
Days to Decision 235 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
113d slower than avg
Panel avg: 122d · This submission: 235d
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 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K152754.
Exactech® Equinoxe® Preserve Stem
K162726 · Exactech, Inc. · Feb 2017
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
K161742 · Tornier, Inc. · Nov 2016
Integra TITAN Reverse Shoulder System
K161189 · Integra LifeSciences Corporation · Aug 2016
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
K150458 · Exactech, Inc. · May 2015
Univers Rivers Shoulder Prosthesis System
K142863 · Arthrex, Inc. · Nov 2014
ENCORE HUMERAL SHOULDER STEM
K141990 · Encore Medical, L.P. · Nov 2014