Cleared Traditional

K202232 - Comprehensive Vault Reconstruction System

K202232 is the FDA 510(k) clearance for Comprehensive Vault Reconstruction System by Biomet Manufacturing Corp. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K202232 · Biomet Manufacturing Corp · Orthopedic device
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Feb 2021
Decision
196d
Days
Class 2
Risk

K202232 is an FDA 510(k) clearance for the Comprehensive Vault Reconstruction System. 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 February 19, 2021 after a review of 196 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 K202232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2020
Decision Date February 19, 2021
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
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 K202232.
OVOMotion Reverse Shoulder Arthroplasty System
K203375 · Arthrosurface, Inc. · Jun 2021
Humeral Eccentric Reverse Metaphysis
K210207 · Medacta International S.A. · Mar 2021
Shoulder System - TiNbN Coating
K203755 · Medacta International S.A. · Mar 2021
DELTA XTEND Reverse Shoulder System
K210167 · DePuy Orthopaedics, Inc. · Feb 2021
Catalyst OrthoScience R1 Reverse Shoulder System
K202611 · Catalyst Orthoscience, Inc. · Feb 2021
LINK Embrace Shoulder System - Reverse Configuration
K200368 · Waldemar Link GmbH & Co. KG · Feb 2021