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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K252623

510(k) cleared

G7® Revision Acetabular System

Zimmer, Inc. · Feb 4, 2026 · K252623

FDA cleared the G7® Revision Acetabular System from Zimmer, Inc. on Feb 4, 2026 under K252623, a traditional 510(k). The device falls under product code LPH, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, regulated at 21 CFR 888.3358 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 19, 2025. The decision came 169 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zimmer, Inc. has 7 other decisions in the tracker over the last 12 months: K260831 (Z1 Hip System), K261683 (Augment Off-Axis Instrument System), K251840 (Zimmer® Persona® Personalized Knee System), K260182 (Avenir® Müller Stem; Avenir Complete Hip System).

Questions & Answers

What did FDA clear under K252623?

K252623 is the FDA 510(k) for G7® Revision Acetabular System, submitted by Zimmer, Inc.. FDA's decision date was Feb 4, 2026, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the G7® Revision Acetabular System?

Zimmer, Inc., based in Warsaw, IN, is the applicant of record for K252623.

How long did the K252623 review take?

FDA received the submission on Aug 19, 2025 and issued its decision on Feb 4, 2026, 169 days later.

← All decisions in February 2026