Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EMPHASYS Acetabular Shell with RapiTite HA

K-Number: K242084 · 2024-10-07

ApplicantDepuy Ireland UC
Decision Date2024-10-07
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPHASYS Acetabular Shell with RapiTite HA is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2024-10-07 under approval number K242084. 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 Shell with RapiTite HA?

EMPHASYS Acetabular Shell with RapiTite HA is a medical device that received FDA 510(k) clearance on 2024-10-07. It is manufactured by Depuy Ireland UC. The 510(k) number is K242084.

When was EMPHASYS Acetabular Shell with RapiTite HA approved by the FDA?

EMPHASYS Acetabular Shell with RapiTite HA received FDA 510(k) clearance on 2024-10-07, under approval number K242084.

What company makes EMPHASYS Acetabular Shell with RapiTite HA?

EMPHASYS Acetabular Shell with RapiTite HA is manufactured by Depuy Ireland UC.

What is the FDA product code for EMPHASYS Acetabular Shell with RapiTite HA?

The FDA product code for EMPHASYS Acetabular Shell with RapiTite HA is LPH.

Related Clinical Trials

NCT05591859 Restoration Anatomic Acetabular Shell Revision Study WITHDRAWN NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT02999009 Trident II Tritanium Acetabular Shell Outcomes Study ACTIVE_NOT_RECRUITING

Other Devices by Depuy Ireland UC

K170748GLOBAL UNITE Platform Shoulder System K202248Attune Revision Sleeve LPS Femoral Adaptors K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology K202098GLOBAL UNITE™ Platform Shoulder System K200854DePuy PINNACLE Dual Mobility Liner K193549SIGMA High Performance (HP) Partial Knee System

View all 48 devices →

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.

↑