FDA 510(k)

Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings

K-Number: K190656 · 2019-12-06

Decision Date2019-12-06

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K190656. 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 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings?

Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Zimmer, Inc.. The 510(k) number is K190656.

When did Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings receive FDA 510(k) clearance?

Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings received FDA 510(k) clearance on 2019-12-06, under 510(k) number K190656.

Who is the listed applicant for Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings?

The FDA product code for Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings is LPH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04754087G7 Acetabular System With Vivacit-E or Longevity Liner PMCF StudyACTIVE_NOT_RECRUITING NCT07207005Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip ArthroplastyRECRUITING NCT04090359Dual Mobility Acetabular Cups in Revision TJARECRUITING NCT04325022Safety and Effectiveness Study of OR3O™ Dual Mobility System in THAACTIVE_NOT_RECRUITING NCT07150221MDR Vivacit-E Elevated StudyENROLLING_BY_INVITATION

Other records listing Zimmer, Inc. as applicant

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing K261683Augment Off-Axis Instrument System K260831Z1 Hip System K251840Zimmer® Persona® Personalized Knee System K260182Avenir® Müller Stem; Avenir Complete™ Hip System K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Related Devices (Code: LPH)

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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.