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FDA 510(k)

EMPHASYS Acetabular System

K-Number: K243977 · 2025-01-22

ApplicantDepuy Ireland UC
Decision Date2025-01-22
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPHASYS Acetabular System is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2025-01-22 under approval number K243977. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPHASYS Acetabular System?

EMPHASYS Acetabular System is a medical device that received FDA 510(k) clearance on 2025-01-22. It is manufactured by Depuy Ireland UC. The 510(k) number is K243977.

When was EMPHASYS Acetabular System approved by the FDA?

EMPHASYS Acetabular System received FDA 510(k) clearance on 2025-01-22, under approval number K243977.

What company makes EMPHASYS Acetabular System?

EMPHASYS Acetabular System is manufactured by Depuy Ireland UC.

What is the FDA product code for EMPHASYS Acetabular System?

The FDA product code for EMPHASYS Acetabular System is LPH.

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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