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FDA 510(k)

Trident® II Acetabular System

K-Number: K171768 · 2017-10-02

ApplicantHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Decision Date2017-10-02
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Trident® II Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K171768. 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 Trident® II Acetabular System?

Trident® II Acetabular System is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K171768.

When did Trident® II Acetabular System receive FDA 510(k) clearance?

Trident® II Acetabular System received FDA 510(k) clearance on 2017-10-02, under 510(k) number K171768.

Who is the listed applicant for Trident® II Acetabular System?

The FDA 510(k) record lists Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trident® II Acetabular System?

The FDA product code for Trident® II Acetabular System is LPH.

Other records listing Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as applicant

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.

K233261Global Modular Replacement SystemK210893Restoration Anatomic ShellK203099Triathlon PKR SystemK191358Trident II Acetabular SystemK182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemK180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

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Related Devices (Code: LPH)

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.

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 OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® 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.

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