FDA 510(k)

Pinnacle Duofix HA Acetabular Cup Prosthesis

K-Number: K192919 · 2019-11-26

Decision Date2019-11-26

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Pinnacle Duofix HA Acetabular Cup Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192919. 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 Pinnacle Duofix HA Acetabular Cup Prosthesis?

Pinnacle Duofix HA Acetabular Cup Prosthesis is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K192919.

When did Pinnacle Duofix HA Acetabular Cup Prosthesis receive FDA 510(k) clearance?

Pinnacle Duofix HA Acetabular Cup Prosthesis received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192919.

Who is the listed applicant for Pinnacle Duofix HA Acetabular Cup Prosthesis?

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

What is the FDA product code for Pinnacle Duofix HA Acetabular Cup Prosthesis?

The FDA product code for Pinnacle Duofix HA Acetabular Cup Prosthesis 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.

NCT06631638EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))RECRUITING NCT0283985014022 ATTUNE Cementless RP Clinical Performance EvaluationACTIVE_NOT_RECRUITING NCT03153449ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITING NCT03153475ATTUNE Revision System in the Revision Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITING NCT06323980INHANCE Stemless Reverse Shoulder IDERECRUITING

Other records listing DePuy Orthopaedics, Inc. as applicant

PMA P070026Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented K252887DePuy ATTUNE™ Knee System K231503CUPTIMIZE™ Advanced K213839DePuy Corail AMT Hip Prosthesis K210167DELTA XTEND Reverse Shoulder System K203167DePuy Corail AMT Hip Prosthesis

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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.