510(k) K252623

G7® Revision Acetabular System by Zimmer, Inc. — Product Code LPH

K252623 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "G7® Revision Acetabular System". The FDA issued a decision of Substantially Equivalent on February 4, 2026. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Zimmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2026
Date Received
August 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type