FDA 510(k)

ACTIS Duofix Hip Prosthesis

K-Number: K202472 · 2020-10-21

Decision Date2020-10-21

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ACTIS Duofix Hip 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 2020-10-21 under 510(k) number K202472. 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 ACTIS Duofix Hip Prosthesis?

ACTIS Duofix Hip Prosthesis is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K202472.

When did ACTIS Duofix Hip Prosthesis receive FDA 510(k) clearance?

ACTIS Duofix Hip Prosthesis received FDA 510(k) clearance on 2020-10-21, under 510(k) number K202472.

Who is the listed applicant for ACTIS Duofix Hip 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 ACTIS Duofix Hip Prosthesis?

The FDA product code for ACTIS Duofix Hip Prosthesis is LPH.

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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.