Cleared Traditional

K140390 - TITANIUM VERSA-DIAL HUMERAL HEAD PROSTH...

K140390 is the FDA 510(k) clearance for TITANIUM VERSA-DIAL HUMERAL HEAD PROSTH... by Biomet Manufacturing Corp. It is a Class 2 Orthopedic device (product code MBF) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K140390 · Biomet Manufacturing Corp · Orthopedic device
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Sep 2014
Decision
208d
Days
Class 2
Risk

K140390 is an FDA 510(k) clearance for the TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS. 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 September 10, 2014 after a review of 208 days - an extended review cycle.

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. 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 K140390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date September 10, 2014
Days to Decision 208 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
86d slower than avg
Panel avg: 122d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
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