Cleared Traditional

DePuy Corail AMT Hip Prosthesis (K190344) - FDA 510(k) Clearance

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

K190344 · Depuy(Ireland) · Orthopedic device
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Nov 2019
Decision
260d
Days
Class 2
Risk

K190344 is an FDA 510(k) clearance for the DePuy Corail AMT Hip Prosthesis. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Depuy(Ireland) (Cork, IE). The FDA issued a Cleared decision on November 1, 2019 after a review of 260 days - an extended review cycle.

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 Depuy(Ireland) devices

Submission Details

510(k) Number K190344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2019
Decision Date November 01, 2019
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
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 Consultant

DePuy Orthopaedics, Inc.
Melissa Cook

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 308
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K190344.
Avenir Muller Stem, Avenir Cemented Hip Stem
K193030 · Zimmer GmbH · Dec 2019
DePuy Corail AMT Hip Prosthesis
K192946 · DePuy Orthopaedics, Inc. · Nov 2019
AMIStem-P Short Neck
K192126 · Medacta International S.A. · Nov 2019
Exactech Alteon Modular Dual Mobility (MDM) System
K190890 · Exactech, Inc. · Oct 2019
PROFEMUR TL2 Stems
K191632 · Microport Orthopedics, Inc. · Oct 2019
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
K192416 · Zimmer GmbH · Oct 2019