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FDA 510(k)

Insignia Hip Stem

K-Number: K211703 · 2021-08-16

ApplicantStryker Orthopaedics
Decision Date2021-08-16
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Insignia Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2021-08-16 under 510(k) number K211703. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insignia Hip Stem?

Insignia Hip Stem is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Stryker Orthopaedics. The 510(k) number is K211703.

When did Insignia Hip Stem receive FDA 510(k) clearance?

Insignia Hip Stem received FDA 510(k) clearance on 2021-08-16, under 510(k) number K211703.

Who is the listed applicant for Insignia Hip Stem?

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

What is the FDA product code for Insignia Hip Stem?

The FDA product code for Insignia Hip Stem is MEH.

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.

NCT05144191Insignia™ Hip Stem Outcomes StudyACTIVE_NOT_RECRUITINGNCT02521103Triathlon Tritanium Cone Augments Outcomes StudyACTIVE_NOT_RECRUITINGNCT02999009Trident II Tritanium Acetabular Shell Outcomes StudyACTIVE_NOT_RECRUITINGNCT05591859Restoration Anatomic Acetabular Shell Revision StudyWITHDRAWNNCT07647354Mako-MORE RegistryRECRUITING

Other records listing 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.

K191414EXETER Centralizer, EXETER 2.5mm PlugK173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsK173849Triathlon Total Knee SystemK172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemK153345Stryker Orthopaedics Hip Systems Labeling Update

Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, 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.

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