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FDA 510(k)

G7® Revision Acetabular System

K-Number: K252623 · 2026-02-04

ApplicantZimmer, Inc.
Decision Date2026-02-04
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G7® Revision Acetabular System is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2026-02-04 under approval number K252623. 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® Revision Acetabular System?

G7® Revision Acetabular System is a medical device that received FDA 510(k) clearance on 2026-02-04. It is manufactured by Zimmer, Inc.. The 510(k) number is K252623.

When was G7® Revision Acetabular System approved by the FDA?

G7® Revision Acetabular System received FDA 510(k) clearance on 2026-02-04, under approval number K252623.

What company makes G7® Revision Acetabular System?

G7® Revision Acetabular System is manufactured by Zimmer, Inc..

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

The FDA product code for G7® Revision Acetabular System is LPH.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05591859 Restoration Anatomic Acetabular Shell Revision Study WITHDRAWN NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04090359 Dual Mobility Acetabular Cups in Revision TJA RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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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