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FDA 510(k)

G7® Acetabular System

K-Number: K261453 · 2026-09-23

ApplicantZimmer Biomet
Decision Date2026-09-23
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G7® Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet. It received FDA 510(k) clearance on 2026-09-23 under 510(k) number K261453. 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 G7® Acetabular System?

G7® Acetabular System is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Zimmer Biomet. The 510(k) number is K261453.

When did G7® Acetabular System receive FDA 510(k) clearance?

G7® Acetabular System received FDA 510(k) clearance on 2026-09-23, under 510(k) number K261453.

Who is the listed applicant for G7® Acetabular System?

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

What is the FDA product code for G7® Acetabular System?

The FDA product code for G7® Acetabular System 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.

NCT01307384Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) StudyCOMPLETEDNCT02038140Zimmer Trabecular Metal Total Ankle PMCFACTIVE_NOT_RECRUITINGNCT02469662Clinical Outcomes Study of the Nexel Total ElbowRECRUITINGNCT02851992A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral StemTERMINATEDNCT03226808Vivacit-E Post-market Follow-up StudyCOMPLETEDNCT03270982Comprehensive Segmental Revision SystemACTIVE_NOT_RECRUITING

Other records listing Zimmer Biomet 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.

K251834Persona Partial KneeK243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersK251620A.L.P.S. Proximal Humerus Plating SystemK250834Zimmer Biomet Ceramic Heads (22.2mm diameter)K243293Zimmer® Persona® Personalized Knee System

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.

K253630Mpact 3D Metal FoamMedacta International S.A.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.

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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