Cleared Traditional

K231522 - EMPHASYS Dual Mobility System

K231522 is the FDA 510(k) clearance for EMPHASYS Dual Mobility System by Depuy Ireland UC. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K231522 · Depuy Ireland UC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
265d
Days
Class 2
Risk

K231522 is an FDA 510(k) clearance for the EMPHASYS™ Dual Mobility System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Depuy Ireland UC (Cork Munster, IE). The FDA issued a Cleared decision on February 15, 2024 after a review of 265 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 UC devices

Submission Details

510(k) Number K231522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2023
Decision Date February 15, 2024
Days to Decision 265 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
143d slower than avg
Panel avg: 122d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 424
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K231522.
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K232667 · Smith & Nephew, Inc. · Oct 2023
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K230011 · Medacta International S.A. · Sep 2023