Cleared Traditional

K153398 - Comprehensive SRS/Nexel Elbow (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153398 · Biomet Manufacturing Corp · Orthopedic device
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Feb 2016
Decision
71d
Days
Class 2
Risk

K153398 is an FDA 510(k) clearance for the Comprehensive SRS/Nexel Elbow. Classified as Prosthesis, Elbow, Constrained, Cemented (product code JDC), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on February 3, 2016 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet Manufacturing Corp devices

Submission Details

510(k) Number K153398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2015
Decision Date February 03, 2016
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDC Prosthesis, Elbow, Constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3150
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.