Cleared Traditional

K201519 - PROFEMUR® GLADIATOR® Cemented Classic Stem

K201519 is an FDA 510(k) clearance for PROFEMUR GLADIATOR Cemented Classic Stem, manufactured by Microport Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K201519 · Microport Orthopedics, Inc. · Orthopedic device
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Dec 2020
Decision
185d
Days
Class 2
Risk

K201519 is an FDA 510(k) clearance for the PROFEMUR® GLADIATOR® Cemented Classic Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on December 10, 2020 after a review of 185 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Microport Orthopedics, Inc. devices

FDA 510(k) Submission Details - K201519

510(k) Number K201519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2020
Decision Date December 10, 2020
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 514
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