DeviceClearance

G7® Revision Acetabular System— 510(k) K252623

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K252623 for G7® Revision Acetabular System, Substantially Equivalent on 2026-02-04. Applicant: Zimmer, Inc.. Device class: 2.

Summary

Zimmer's G7® Revision Acetabular System is filed under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 888.3358. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

Zimmer filed from Warsaw, Indiana. Review took 169 calendar days (August 19, 2025 to February 4, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant
Zimmer, Inc.
Product code
Product code LPH
Device class
Class 2
Regulation
21 CFR 888.3358
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LPH

product code LPH
Death
73
Injury
31,640
Malfunction
3,358
Other
2
Total
35,073

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.