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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K261453

510(k) cleared

G7® Acetabular System

Zimmer Biomet · Sep 23, 2026 · K261453

FDA cleared the G7® Acetabular System from Zimmer Biomet on Sep 23, 2026 under K261453, 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 May 1, 2026. The decision came 145 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Zimmer Biomet in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261453?

K261453 is the FDA 510(k) for G7® Acetabular System, submitted by Zimmer Biomet. FDA's decision date was Sep 23, 2026, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the G7® Acetabular System?

Zimmer Biomet, based in Warsaw, IN, is the applicant of record for K261453.

How long did the K261453 review take?

FDA received the submission on May 1, 2026 and issued its decision on Sep 23, 2026, 145 days later.

← All decisions in September 2026