Cleared Traditional

K200007 - PROFEMUR GLADIATOR Thin HA Classic Hip ...

K200007 is the FDA 510(k) clearance for PROFEMUR GLADIATOR Thin HA Classic Hip ... by Microport Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K200007 · Microport Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
114d
Days
Class 2
Risk

K200007 is an FDA 510(k) clearance for the PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on April 25, 2020 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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

Submission Details

510(k) Number K200007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2020
Decision Date April 25, 2020
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K200007.
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
K200959 · Biomet UK, Ltd. · Jul 2020
Cemented TSI Hip Stem
K192024 · Signature Orthopaedics Pty, Ltd. · Jun 2020
M-Vizion Femoral Revision System Extension
K191816 · Medacta International S.A. · Apr 2020
Zimmer Hip Joint Replacement
K200112 · Zimmer GmbH · Apr 2020
Zimmer M/L Taper Hip Prosthesis
K192660 · Zimmer, Inc. · Feb 2020
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
K192683 · Biomet UK, Ltd. · Feb 2020