Cleared Traditional

K214001 - Comprehensive Shoulder System

K214001 is the FDA 510(k) clearance for Comprehensive Shoulder System by Biomet Manufacturing Corp. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K214001 · Biomet Manufacturing Corp · Orthopedic device
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Mar 2023
Decision
449d
Days
Class 2
Risk

K214001 is an FDA 510(k) clearance for the Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder 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 March 15, 2023 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Biomet Manufacturing Corp devices

Submission Details

510(k) Number K214001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2021
Decision Date March 15, 2023
Days to Decision 449 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
327d slower than avg
Panel avg: 122d · This submission: 449d
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 K214001.
FX V135(TM) Shoulder Prosthesis
K223801 · Fx Shoulder USA, Inc. · Jun 2023
Catalyst R1 Reverse Shoulder System
K223655 · Catalyst Orthoscience, Inc. · May 2023
Arthrex Univers Revers Monoblock Stem Size 4/33
K230366 · Arthrex, Inc. · Apr 2023
INHANCETM Shoulder System – Humeral Stems and Stemless
K223211 · Depuy Ireland UC · Dec 2022
Glenoid Reconstruction System
K213459 · Medacta International S.A. · Nov 2022
Humeris® 135 Shoulder System
K222936 · Fx Shoulder USA, Inc. · Nov 2022