Cleared Traditional

K261453 - G7® Acetabular System

K261453 is an FDA 510(k) clearance for G7 Acetabular System, manufactured by Zimmer Biomet. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K261453 · Zimmer Biomet · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
145d
Days
Class 2
Risk

K261453 is an FDA 510(k) clearance for the G7® Acetabular System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Zimmer Biomet (Warsaw, US). The FDA issued a Cleared decision on September 23, 2026 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer Biomet devices

FDA 510(k) Submission Details - K261453

510(k) Number K261453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2026
Decision Date September 23, 2026
Days to Decision 145 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 122d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 555
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K261453.
Mpact 3D Metal Foam
K253630 · Medacta International S.A. · Aug 2026
TRIVANCE™ Hip Stem
K254043 · Globus Medical, Inc. · Aug 2026
Omnifit® 20° Series I Insert
K261624 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jul 2026
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
K243192 · Nextstep Arthopedix, LLC · Jun 2026
Taperloc® Complete Hip Stem
K251270 · Biomet, Inc. · May 2026
G7® Revision Acetabular System
K252623 · Zimmer, Inc. · Feb 2026