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EMPHASYS Acetabular System

by DePuy Ireland UC 2 variants

510(k) K243977

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK243977 Date22 Jan 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LPH
Device class
Class II
Regulation
21 CFR Part 888.3358
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Emphasys Acetabular System is a semi-constrained hip prosthesis designed for use in orthopedic surgical procedures. It functions as an acetabular component to support hip joint reconstruction.

This device is identified by FDA 510(k) number K243977 and is classified under product code LPH. It has received FDA 510(k) clearance through the Special 510(k) pathway.

Other devices from DePuy Ireland UC

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the EMPHASYS Acetabular System?

    The EMPHASYS Acetabular System is a semi-constrained hip prosthesis intended for use in orthopedic surgical procedures. It serves as an acetabular component to provide structural support during hip joint reconstruction.

  • What is the regulatory status of this device?

    The EMPHASYS Acetabular System has received FDA 510(k) clearance, identified by submission number K243977. It was cleared through the Special 510(k) pathway and is classified under product code LPH.

  • Who is the manufacturer of the EMPHASYS Acetabular System?

    This device is manufactured by DePuy Ireland UC, located in Loughbeg, Ringaskiddy, Cork, Ireland.