Cleared Traditional

K193038 - Comprehensive Shoulder System

K193038 is an FDA 510(k) clearance for Comprehensive Shoulder System, manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code MBF cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K193038 · Biomet Manufacturing Corp · Orthopedic device
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Oct 2020
Decision
363d
Days
Class 2
Risk

K193038 is an FDA 510(k) clearance for the Comprehensive Shoulder System. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (product code MBF), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 28, 2020 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3670 - 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K193038

510(k) Number K193038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2019
Decision Date October 28, 2020
Days to Decision 363 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
241d slower than avg
Panel avg: 122d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBF Device Classification - Class 2, Special Controls

Product Code MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3670
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 - MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

All 36
Devices cleared under the same product code (MBF) and FDA review panel - the closest regulatory comparables to K193038.
SMR Reverse Liner
K220792 · Lima Corporate S.P.A. · May 2022
Ignite Anatomic Shoulder System
K202716 · Ignite Orthopedics, LLC · May 2021
SMR 140° Reverse Humeral Body
K201905 · Lima Corporate S.P.A. · Dec 2020
SMR Finned Short Stems
K191963 · Lima Corporate S.P.A. · Oct 2019
Compress and Mini Compress Anti-Rotation Spindles
K183553 · Biomet, Inc. · Jan 2019
Humeral Short Stem System
K173824 · Shoulder Innovations, Inc. · Oct 2018